Home >> News
News

New Industry News


Specialty Pharma Industry News (November 2018)

Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos

 

November 27

FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions.   FDA issued a warningletter 

to Pharm D in December 2016 following an inspection. During FDA's recent follow-up inspection of Pharm D's compounding facility in August 2018, investigators observed insanitary conditions, including poor sterile production practices and deficient environmental monitoring. These conditions raised concerns about the company's ability to assure the sterility of its drug products. Pharm D resumed sterile operations on October 8, 2018, and distributed purportedly sterile products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on November 9, 2018, but has not agreed to FDA's recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk.

 

November 19

FDA Completes Review of Qualified Health Claim Petition for Oleic Acid and the Risk of Coronary Heart Disease.  The U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease.  Oleic acid is a monounsaturated fat which, when substituted for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease.  "Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease."

 

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap'n Crunch's Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk. Quaker is initiating the voluntary recall to protect public health due to the potential presence of Salmonella.  Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

 

November 16

FDA approves new treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli.  The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. The most common adverse reactions with Aemcolo were headache and constipation.   Travelers' diarrhea is defined by having three or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most commonly bacteria found in food and water. The highest-risk destinations are in most of Asia as well as the Middle East, Africa, Mexico, and Central and South America.

 

FDA Reminds Parents Not to Feed Honey to Children Younger Than 1 Year: Honey Pacifiers Suspected in Texas Infant Botulism Cases.  The FDA has received reports from the state of Texas that four infants have been hospitalized with botulism. All four infants had used pacifiers containing honey. These pacifiers were purchased in Mexico, but similar products also appear to be available in the U.S. through online retailers.

 

FDA approves new first-line treatment for peripheral T-cell lymphoma under a new review pilot.  The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.  PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells. The T-cells often spread quickly throughout the body and are hard to treat.

 

November 15

FDA Intends to Extend Comment Period on Use of the Names of Dairy Foods in Labeling Plant-Based Products.  The U.S. Food and Drug Administration is announcing its intention to extend by 60 days the comment period on the request for information on labeling plant-based products with names that include the names of dairy foods, such as "milk," "yogurt," and "cheese." The original comment period was scheduled to end on November 27.  To submit electronic comments, go to https://www.regulations.gov to Docket Folder FDA-2018-N-3522.

 

November 14

CDER SIBA Webinar:  Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Thursday December 6, 2018, 1:00 PM - 2:00 PM EDT.  View Agenda and Register Here

 

Warning Letters

Grand Rapids E-Liquid, Grand Rapids, MI 49525

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.sendmyeliquid.com and determined that the e-liquid products listed there are offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a (b)). FDA has determined that your Neapolitan Ice Cream e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age.

 

November 13

FDA releases draft guidance for industry entitled "Nonmetastatic, Castration-Resistant Prostate Cancer:  Considerations for Metastasis-Free Survival Endpoint in Clinical Trials."  Additional information is available in the Federal Register Notice.

 

Guidance for Industry Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry   Download with control/click on the colored title above.

 

FDA will hold a public meeting entitled "Drug Development Tool Process under the 21st Century Cures Act and Prescription Drug User Fee Act VI." 

This meeting will provide an opportunity for public input regarding the drug development tools qualification pathway for animal models, biomarkers, and clinical outcome assessments.  The FDA is holding this public meeting to discuss taxonomy for biomarkers and related concepts used in drug development, and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.  In addition to providing input at the public meeting, stakeholders are invited to submit comments through the public docket. Electronic or written comments can be submitted to the docket through January 31, 2019. 

 

November 9

FDA highlights record-breaking number of generic drug approvals in October.  The U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.  In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition and 17 complex generics.

 

FDA approves new drug for maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD).  Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist (LAMA), which is a class of medicines that improve lung function in patients with COPD. Revefenacin is an inhalation solution that is administered once daily via a standard jet nebulizer.  For more information, please visit: Yupelri (revefenacin) Inhalation Solution

 

FDA updates on angiotensin II receptor blocker (ARB) recalls: Sandoz's losartan potassium and hydrochlorothiazide nationwide recall of one lot due to NDEA.  Losartan, is an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension.   Sandoz's product was made using an active pharmaceutical ingredient (API) that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.  FDA continues to investigate the presence of NDEA and NDMA, which are probable human carcinogens, in ARBs and is taking swift action when it identifies unacceptable impurities in API and finished drug products.

 

November 8

The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle

These products are labeled as a homeopathic and are being recalled due to non-sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or health care provider if they experience any problems that may be related to using this product.  Use of a non-sterile eye drop product is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of this product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye, which can lead to scarring, glaucoma or vision loss.

 

A new version Primatene Mist (epinephrine) metered-dose inhaler has been approved for Over-the-Counter use to provide temporary relief for symptoms of mild, intermittent asthma.  

This OTC drug is approved only for those who have been diagnosed with asthma by a health care provider.   Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It's important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a health care professional.

 

November 6

Guidance for Industry   (click or control/click on the title to download) Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for IndustryChronic Hepatitis B Virus Infection: Developing Drugs for Treatment 

 

November 5

CDER SBIA Chronicles:  FDA Facilitates the Use of Surrogate Endpoint in Drug DevelopmentDownload your copy by Control/Click on:    Download (PDF - 181KB)

 

FDA Finalizes Guidance on Mandatory Recall Authority.   

The U.S. Food and Drug Administration has released a 

final guidance regarding the agency's mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).  The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.  This final guidance follows a draft which was made available for public comment in 2015, and provides additional clarity including some modifications based on comments received.  

FDA has issued a mandatory recall order of a food product only once. In April 2018, FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain Salmonella. 

 

November 2

FDA alerts patients and health care professionals that some EpiPen (epinephrine) auto-injectors may not readily slide out of carrier tube.   FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.  In a letter to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.  It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

 

FDA approved Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim). 

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. For more information about biosimilar products, visit www.fda.gov/biosimilars

 

Electronic Submission of approved ANDAs is now available through CDER Direct NextGen Collaboration Portal.  As of October 1, 2018, generic drug applicants and their affiliates, or an authorized representative, can submit a list of their approved ANDAs to the FDA for the remainder of GDUFA II (2020-2022), through the CDER Direct NextGen Collaboration Portal. Submissions are due by April 1 of the year prior to the fiscal year they reflect. For example, submissions for FY2020 are due by April 1, 2019. Submitting this information electronically will streamline the process and facilitate two-way communication between applicants and the Office of Management at the FDA.  To submit your list of approved ANDAs for fiscal years 2020-2022, you must first register for a CDER Direct NextGen Collaboration Portal account at  https://edm.fda.gov.  For more information, including general questions, or to request a login, login instructions, and contact information, visit the CDER Direct NextGen Collaboration Portal FAQs.

 

FDA Issues Two Guidances on Nutrition Facts Label Issues.

The U.S. Food and Drug Administration today issued one draft and one final guidance on various topics related to the two final rules updating the Nutrition Facts label.  The first guidance, which is draft, "

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics: Guidance for Industry," includes sections relating to:

  • the definition of a single-serving container,
  • reference amounts customarily consumed, which are used by companies to determine serving size,
  • dual-column labeling, and
  • miscellaneous issues, such as requirements relating to chewing gum and to multi-unit retail food packages.

The second guidance, which is final, is "Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry." The majority of the guidance consists of questions and answers to help manufacturers determine how to calculate "added sugars" in their products under certain circumstances. Other topics include compliance, label formats, and the declaration of quantitative amounts of vitamins and minerals.  The guidances are meant to provide clarity to food manufacturers to help them comply with the FDA's updated labeling regulations, which are required by January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will have an additional year to comply.   To ensure that comments on the draft guidance are reviewed before work begins on the final guidance, please submit them either electronically or in writing within 60 days of the date of the draft guidance's publication in the Federal Register. 

 

Submit electronic comments to the Federal eRulemaking Portal: https://www.regulations.gov. Written comments can be submitted to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

 

November 1

FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications.  The FDA has become aware of genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of side effects compared to other medications due to genetic variations.  There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA approved medications. The FDA authorized labels for these medical products may provide general information on how DNA variations may impact the levels of a medication in a person's body, or they may describe how genetic information can be used in determining therapeutic treatment, depending on the available evidence.   Recommendations for Patients: Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence. Do not change or stop taking any medicine based on a report from a genetic test you took on your own and discuss the results with your healthcare provider.

 

 


Specialty Pharma Industry News (October 2018)

 

Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos

 

October 31

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg.  Irbesartan tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.  These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited.  This impurity, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC)

FDA approved Hyrimoz (adalimumab-adaz) for multiple indications. Hyrimoz is administered by injection. This is the third FDA-approved biosimilar to U.S.-licensed Humira.

 

October 30

Guidance for Industry:

Testicular Toxicity: Evaluation During Drug Development Guidance for Industry Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry    Download either guidance by Control/click on the colored titles above.

 

October 25

Extended Use Dates Provided by Impax Generics to Assist with Epinephrine Auto-Injector Intermittent Supply Interruptions.  Due to the intermittent supply interruptions of epinephrine auto-injectors, FDA is alerting health care professionals and patients of updated dates through which some Epinephrine Injection, USP, 0.15 mg and 0.30 mg auto-injectors, distributed by Impax Generics, may be used beyond the manufacturer's labeled expiration date. To help ensure patient safety, these products should have been-and should continue to be-stored as labeled.

 

October 24

FDA approves new drug to treat influenza.   The U.S. Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.  The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

 

October 23

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer.  U.S. District Judge John T. Fowlkes, Jr. for the Western District of Tennessee entered a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee, the company's owner, Melinda Menke, and its president, Elizabeth Jumet. According to the complaint filed with the consent decree, Keystone manufactured and distributed OTC hair care and skin care products that violated federal law.   For example, Keystone failed to adequately investigate sources of contamination found in some of its products and failed to ensure its drug products met their specifications before releasing them to consumers. Some of Keystone's drugs were also misbranded because the product labels did not include adequate directions for use or other label requirements for OTC drug products.

 

Probiotic bacteria block harmful microbe   Researchers identified how Bacillusbacteria, which are used in many probiotic formulations, can prevent the growth of harmful Staphylococcus aureus, or "staph," bacteria.  Read more by Control/Click on the colored title above.

 

October 22

Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements  Download your copy by Control/Click on the colored title.

 

October 19

Warning Letters 

Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts, Wichita, Kansas

Based on our inspection in 2017 it appears that you produced drug products that violate the Food Drug and Cosmetic Act (FDCA).  

 

1)  Receipt of valid prescriptions for individually identified patients is one of the conditions for the exemptions under section 503A of the FDCA and your firm did not have valid prescriptions for the drug products you produced.

 

2)  Your firm compounded drug products using dinitrochlorobenzene or magnesium glycinate. Drug products compounded using dinitrochlorobenzene or magnesium glycinate are not eligible for the exemptions provided by section 503A(a) of the FDCA [21 U.S.C. § 353a(a)], because dinitrochlorobenzene and magnesium glycinate are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list. 

 

3)  An employee sanitized their gloves in the near vicinity of open vials within the ISO 5 hood.

 

4)  An improper cleaning agent (household dish detergent) was used to wash glassware used in sterile drug production.

 

5)  Media fills failed to closely simulate aseptic production operations under the most challenging or stressful conditions.  

 

6)  You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.

 

7)  The ineligible drug products you compounded are misbranded under section 502(f)(1) of the FDCA 

 

October 16

NIH Research Matters:  Fecal transplants restore gut microbes after antibiotics.  

The very high doses of chemotherapy or radiation therapy that are used to treat certain cancers can destroy blood-forming stem cells in the bone marrow. Stem cell transplants can restore these cells and re-establish the bone marrow's production of blood cells and immune function.  Stem cell recipients are given antibiotics to prevent serious bacterial infections.  

 

Unfortunately, antibiotics also unintentionally destroy these beneficial bacteria and thus increase the risk of life-threatening infections as well as graft-versus-host disease.  Fecal samples were obtained from patients and frozen and stored prior to their stem cell transplantation procedure. One to five weeks later, when physicians confirmed that the transplanted stem cells had established, they assessed the patients' beneficial gut bacteria. The first 25 patients who lacked known beneficial bacteria were enrolled in the study and randomly assigned to two different treatment groups: 14 received the autologous fecal transplant by enema and 11 received standard care.  Auto-FMT restored beneficial gut bacteria within days. With standard care, beneficial gut bacteria typically take many weeks to recover from antibiotic treatment.

 

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine   Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

 

October 15

FDA announces Draft Guidance on Rare Diseases:   "Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings"   It will assist sponsors of drug and biological products for the treatment of rare diseases in conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings.

 

October 11

FDA alerts consumers of Sprayology's voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination at the King Bio Inc., manufacturing facility in Asheville, NC. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention.  Previously FDA alerted consumers to four other voluntary recalls related to King Bio's recall:


Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series Stem Cell Products Manufactured by Genetech, Inc.  The Center for Biologics Evaluation and Research (CBER), a division of the Food and Drug Administration (FDA), which oversees human cells and tissue-based products, contacted Liveyon on Thursday, September 28, 2018. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series® product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions.


Recently Posted Guidance Documents

 

October 10

 Webinar Recording Available: Writing the "Indications and Usage" Section of Labeling: FDA's New Draft Guidance.  To anyone who had difficulty joining the September 27th webinar, please pardon our technical limitations as the number participants exceeded capacity. The recording is available in video or audio.  Control/Click on the following to view and/or Listen.  Webinar Recording Available: Writing the "Indications and Usage" Section of Labeling: FDA's New Draft Guidance 

 

Guidance for Industry  

FDA publishes new recommendations for industry regarding Transdermal and Topical Delivery Systems for ANDAs (double click on titles below to read)

Product-Specific Guidances for Generic Drug Development (updated, 2 new guidances, 23 revisions)

Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft      Guidance for Industry (PDF - 187KB)  

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for  ANDAs Guidance for Industry (PDF - 235KB) 

 

What is the point of "heating" medicinal products to 15-25º C?   (Editor's note: I have often wondered why most products can't be stored at cooler temperatures than the "Controlled Room Temperature" range required in the regulations.)   Read this article at:

https://www.gmp-publishing.com/en/lead-article/gmp-aktuell/gmp-logfile-37-2018-heating-medicinal-products.html

 

October 8

LaCroix Faces Lawsuit for Allegedly Including Cockroach Insecticide Ingredient in its Sparkling Water.  A lawsuit filed against LaCroix's parent company alleges the sparkling water advertised as "all natural" includes an ingredient used in cockroach insecticide as well as other artificial ingredients.   "These chemicals include limonene, which can cause kidney toxicity and tumors; linalool propionate, which is used to treat cancer; and linalool, which is used in cockroach insecticide."  National Beverage Corp. denies the allegations, saying all essences in LaCroix sparkling waters are all 100 percent natural.  "The United States Food and Drug Administration (FDA) considers "natural" on a food label to be truthful and non-misleading when 'nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added,'" the company said in a statement earlier this week.

 

October 5

FDA Removes 7 Synthetic Flavoring Substances from Food Additives List.  The FDA determined that the data presented in one of the petitions submitted to the FDA by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff show that 6 of these synthetic substances (benzophenone, Ethyl Acrylate, Methyl Eugenol, Myrcene, Pulegone, and Pyridine) caused cancer in laboratory animals under the conditions of the studies. The seventh synthetic flavor(Styrene) is being de-listed because it is no longer used by industry.

 

October 2

 More Guidance for Industry

Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry (PDF - 167KB)

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 195KB)

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs Guidance for Industry (PDF - 71KB)

 

"Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use."

 

FDA Approves First Treatment for Advanced Form of the Second Most Common Skin Cancer.  The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.  Common side effects of Libtayo include fatigue, rash and diarrhea.  Libtayo can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter 'gaming' of the generic drug approval process by the use of citizen petitions.  "One area of focus has been shutting down practices used by branded firms to "game" the system and take advantage of certain rules, or exploit loopholes, to delay generic approval - thereby extending a drug's monopoly beyond what Congress intended. To address these goals, today, the FDA has issued a revised draft guidance designed to allow for a more efficient approach to 505(q) petitions and allow us to focus more reviewer resources on scientific reviews."

 

Guidance for Industry
Insanitary Conditions at Compounding Facilities Guidance for Industry

ANDA Submissions - Content and Format of Abbreviated New Drug Applications

 

October 1

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Do, sing Information on Label.  The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death "four tablets four times daily" rather than the correct dosage of "two tablets three times daily." 

 

New Feature! Submit controlled correspondence through the CDER Direct NextGen Collaboration Portal.  Effective today, October 1, 2018, generic drug manufacturers and related industry (or their authorized representatives) can submit controlled correspondence via the CDER Direct NextGen Collaboration Portal.  To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov.   Under the 'Login' section on the right of the screen, click on 'New User'. On the 'Request a Login' page, check the 'Controlled Correspondence' event and provide all pertinent information such as contact information, organization information, and security questions. After submitting, your request will be validated, and you will receive an email with a confirmation/activation link.

 

For more on logging in:

CDER Direct NextGen Collaboration Portal FAQs

Please see FDA's Draft Guidance for Industry, Controlled Correspondence Related to Generic Drug Development for additional information on FDA's consideration of controlled correspondence.

 

 


 

Specialty Pharma Industry News (September 2018)

September 29

Guidance for Industry - DSCSA Grandfathering policy for Packages and Homogenous Cases of Product Without a Product Identifier 

Download your copy here.

Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy. Get your copy here.

Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers.  Read your copy here.

 

September 28

The U.S. Food and Drug Administration (FDA) issued the draft guidance titled, "Adaptive Design for Clinical Trials of Drugs and Biologics"  for public comments.  This guidance will help sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications develop appropriate adaptive clinical trial designs to support the effectiveness and safety of a drug or biologic. When finalized, this guidance will represent FDA's current thinking on this topic.

The FDA has published a draft guidance entitled "Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications" This draft guidance will assist sponsors of drug and biological products that are the subject of an investigational new drug application (IND), a new drug application (NDA), a biologics license application (BLA) and certain drug-device combination products submitted in Abbreviated New Drug Applications (ANDAs), to streamline the submission process, thereby helping to increase the efficiency of the review process. (For a copy click here.)

The US Food and Drug Administration (FDA) approved Emgality (galcanezumab-gnlm) for the preventative treatment of migraine in adults. This is the third FDA-approved biologic that acts by reducing the effect of CGRP, a molecule believed to play a role in migraine.  Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018.  A migraine is described as severe throbbing pain or a pulsing sensation, usually on just one side of the head. It's often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can cause significant pain for hours to days and can be so severe that the pain is disabling. Warning symptoms known as aura may occur before or with the headache. These can include flashes of light, blind spots, or tingling on one side of the face or in the arm or leg.

 

The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance Master Protocols- Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.  

This guidance provides advice to pharmaceutical sponsors, the academic community, institutional review boards, and the public on aspects of master protocol designs and trial conduct that pose additional regulatory consideration, such as biomarker development and statistical analysis considerations, and provides advice on the information that sponsors should submit to FDA and how sponsors can interact with FDA to facilitate efficient review.

 

September 27

FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela As of September 27 2018, a total of 26 laboratory-confirmed cases of Vibrio parahaemolyticus infection were reported in people who ate fresh crab meat from Venezuela; the cases were reported by seven states [CO (1), DE (2), LA (2), NY (1), PA (1), VA (1)] and the District of Columbia (3 cases).  Consumers and restaurants may want to consider using pasteurized crab meat or fully recooking (bringing to an internal temperature of at least 165°F) fresh crab meat, particularly for items that will be served cold.

FDA is Asking for Input on Use of the Names of Dairy Foods in Labeling Plant-Based Products. The U.S. Food and Drug Administration is issuing a request for information as it examines its approach to the use of dairy food names like "milk," "cheese," or "yogurt" in the labeling of plant-based foods and beverages. Many dairy products, such as milk, yogurt, and certain cheeses, have standards of identity set by regulation. The regulations were established under the foods' common or usual names, such as "milk," "yogurt," and "cheddar cheese." These names have continued in common usage and are recognized by the American public as identifying the dairy foods described in the standards.  More recently, these names have appeared in the labeling of plant-based products as part of the name or statement of identity of the product.  Some examples include "soy milk" or "almond milk" and "vegan mozzarella cheese."  To submit electronic comments, go to https://www.regulations.gov. 

 

September 26

The FDA has Completed Its Investigation of the Multistate Outbreak of Salmonella Mbandaka Infections Linked to Kellogg's Honey Smacks Cereal.  The CDC also reports that this outbreak investigation is over.  Consumers should not eat and should discard Honey Smacks cereal with a "best if used by" date of June 14, 2019 or earlier.

 

Live CE Webinar on the FDA Adverse Event Reporting System (FAERS) sponsored by the Division of Drug Information    It will be held on October 9, 2018, from 1:00 PM to 2:00 PM (EDT).  To register for the online meeting, please visit:
https://collaboration.fda.gov/ddi100918/event/registration.html  The objectives are:  To explain how to utilize FDA's drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes, and to describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care.

 

September 25

Daily Low Dose Aspirin Shows No Benefit for Healthy Adults.   A large clinical trial found that a daily low dose aspirin in healthy older adults didn't prolong life or help prevent heart disease, physical disability dementia, or stroke.  It does have benefit for those who have had a heart attack or stroke.  This trial was started in 2010 and supported in part by NIH's National Institute on Aging and the National Cancer Institute (NCI).

Guidance for Industry 

Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers  Download at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm621044.pdf

Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Questions and Answers     Get your copy at:  https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm180790.pdf

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier    Find it at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm586509.pdf

Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy Guidance for Industry  Download at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm565272.pdf 

 

 

September 24

Guidance for Industry - Good Review Management Principles for New Drug Applications    This guidance can be found here.

ANDA Submissions - Content and Format of Abbreviated New Drug Applications   This Guidance lays out the agency's plans to streamline the ANDA assessment process, provide clarification and assistance to current and prospective applicants, and, ultimately, expand access to lower cost, high quality medicines.  Get it here.

 

September 23

New Estimates of Americans with Alzheimer's Disease and Related Dementias Show Racial and Ethnic Disparities.  Percentage of Adults age 65 and older with alzheimer's Disease:  Non - Hispanic White 10%; Hispanics 12%; and Black 14%. The U.S. burden of Alzheimer's disease and related dementias (ADRD) is projected to nearly triple by 2060 from 5 million to 14 million, according to a new study from the Centers for Disease Control and Prevention. The study, published online in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, is the first to forecast Alzheimer's disease by race and ethnicity.

 

September 20

CDER SBIA Chronicles:  Real-Time Review of Drug Applications Now a Reality.  Print your copy here.

 

September 19

Duy Drugs, Inc., Doral, Florida  33126-1111

During a recent inspectionFDA collected a sample of your product, "Vegetal Vigra Special for men" ("Vegetal Vigra") and confirmed through laboratory analysis that the sample contained undeclared sildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor that is the active pharmaceutical ingredient (API) in Viagra™.  The undeclared sildenafil in "Vegetal Vigra" causes this product to be a misbranded drug. 

Innovative Intrathecal Solutions, Inc., dba Innovative Compounding, Murrieta, CA 92562

During our inspection in 2017,  the investigators noted that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA. Specifically, the investigators noted your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.  The investigators also noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.  For example, use of non-sterile wipes, cleanroom contained difficult to clean items such as hand held calculator, computer keyboard, and pieces of paper. In addition, your firm lacked adequate system for cleaning and disinfecting the room and equipment, failed to maintain the building to prevent contamination, failed to validate aseptic and sterilization processes, failed to have employees wear appropriate clothing, failed to establish a system for monitoring environmental conditions in aseptic processing areas, failure to follow a written testing program to assess the stability of products, and failure to test each batch for conformance to specifications.

 

September 18

National Institutes of Health Research Matters: Fasting increases health and lifespan in male mice.  

Long periods of fasting between meals helped male mice live longer and healthier lives, regardless of the content of their diets.  More studies are needed to confirm these results and understand how different fasting periods may impact health.  Within these two groups, the researchers divided the mice into three feeding regimens. One had access to a food dispenser at all hours of the day (ad libitum, AL). A calorie restricted (CR) group received 30% less food than the AL group, placed into their cage once a day at the same time. A meal fed, or MF, group was given the same amount of food as the AL mice on average, but was fed only once a day.  The mice were monitored over the course of their natural lives. Mice that died were examined for evidence of disease, including cancer and liver damage. The results were published on September 6, 2018, in Cell Metabolism.  The researchers had expected that mice eating the whole foods-based diet would have a survival advantage when calorie restricted. But this is not what they observed. Diet composition did not affect health and lifespans. However, the periods of fasting did.  Compared with mice in the AL groups, mice in the MF groups lived about 11% longer, even though their total food intake and body weights were similar. Mice in the CR group lived about 28% longer. Mice in the CR and MF groups also developed disease later than mice in the AL groups.

 

September 17

No evidence that high levels of "bad" cholesterol cause heart disease, doctors' claim.  And with this claim, a number of leading cardiologists from the UK, US, Ireland, Italy, Sweden, France and Japan say statins, taken by millions of people to tackle cholesterol, don't have any benefit; consequently, "We suggest clinicians should abandon the use of statins and PCSK-9 inhibitors." But while they do agree that they are a lifesaver for people who have already had a heart attack, the study based on about 1.3 million patients' data indicates statins can be of no use as a preventative measure.  These findings were published in the Expert Review of Clinical Pharmacology.

{Editor's note:  This conclusion was proclaimed at the Doctor's for Disaster Preparedness Conference several years ago.  In addition, the speaker claimed that long term use of statins can cause heart attack and dementia.  Please consult your physician before making changes to your medicine intake.}

 

Registration Open: FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials - Are We There Yet? October 23-24, 2018

 

Registration & Agenda

This event is free to the public. You may attend in-person or via webcast.

Location: Webcast or Tommy Douglas Conference Center (TDCC) 10000 New Hampshire Avenue, Silver Spring, MD 20903

 

This workshop will provide US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Medicines and Healthcare products Regulatory Agency UK (MHRA) perspectives on the importance of quality management practices on data reliability. It will provide regulatory perspectives on data management, data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials. The workshop participants will have opportunities to work on relevant case studies on these topics.

 

September 14

FDA approves new drug for preventive treatment of migraines in adults.  Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. Aimovig (erenumab-aooe), the first in this class, was approved on May 17, 2018.  Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity reactions, including rash, pruritis (itching), drug hypersensitivity, and urticaria (hives) were reported with Ajovy in clinical trials.

 

FDA alerts consumers not to use products distributed by Years to Your Health.  The U.S. Food and Drug Administration is alerting consumers not to use any products made by Years to Your Health of Irving, Texas. FDA is concerned these products could put consumers at risk for serious infection because they are made in a facility with poor manufacturing practices.  Years to Your Health markets hundreds of products online and in its retail store.

 

September 13

The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.   Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.  Common side effects of Lumoxiti include infusion-related reactions, swelling caused by excess fluid in body tissue (edema), nausea, fatigue, headache, fever (pyrexia), constipation, anemia and diarrhea.

On August 1, 2018, the Ministry of Health of the Democratic Republic of Congo reported an outbreak of Ebola virus disease in North Kivu Province.   This is the 10th Ebola outbreak in DRC since the virus was discovered in 1976 in the Democratic Republic of Congo. CDC has issued a Level 1 travel notice, advising travelers of the current outbreak in the DRC. For the most current information about this outbreak, including the most up to date number of cases, see WHO's Ebola situation reports.  Ebola virus disease, previously known as Ebola hemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebolavirus species. Ebolaviruses are found in several African countries. The first Ebola virus was discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa. Based on evidence and the nature of other similar viruses, researchers believe that Ebola is animal-borne (zoonotic) and that bats are the most likely reservoir.


September 10

On September 10, 2018, the FDA published the guidance for industry Technical Specifications-Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications.

This guidance provides recommendations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for abbreviated new drug applications (ANDAs) should be submitted using FDA-supported data standards located in the FDA Data Standards Catalog. This guidance provides additional information related to the guidance for industry Providing Regulatory Submissions in Electronic Format - Standardized Study Data.   By providing extensive technical details and example data tables, this guidance may help generic drug applicants to design better studies, capture critical data, and submit their results as part of a complete ANDA.

 

Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB)Download your copy by control/click on the above colored title.

 

Recently Posted Guidance Documents

Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry

Nonallergic Rhinitis: Developing Drug Products for Treatment

Physiologically Based Pharmacokinetic Analyses - Format and Content Guidance for Industry

Control/Click on the colored title to view and download.

 

September 7

FDA has approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue)for the maintenance treatment of opioid dependence.This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.   Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should only be used after patient induction and stabilization up to a dose of 16 milligrams of buprenorphine using another marketed product.  These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled "Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC)." 

This public meeting is intended to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the 2017 Federal Register notice (FRN), "Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies." FDA will use the information from the public meeting to improve the usability of the proposed data standards.   The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018. Registration and additional information is available HERE.

 

September 6

FDA Issues Draft Guidance on the Labeling of Dietary Supplements Containing Live Microbials. The U.S. Food and Drug Administration today issued draft guidance to advise firms that manufacture, market, or distribute dietary supplements that contain live microbial ingredients of the conditions under which we intend to exercise enforcement discretion to allow firms to declare, in the Supplement Facts label, the quantity of live microbials in colony forming units (CFUs), in addition to the quantitative amount by weight required by regulation.  The FDA also issued a response to a citizen petition from the International Probiotics Association requesting that we amend 21 CFR 101.36 to allow probiotic ingredients to be labeled by CFUs instead of by weight. FDA denied the request to amend our regulations, in order to allow for further evaluation of methods to enumerate live microbials.

 

Specialty Pharma Industry News (August 2018)
August 31
FDA announces voluntary recall of Montelukast Sodium Tablets (Lot MON17384, Expiry 12/31/2019) by Camber Pharmaceuticals due to incorrect drug in bottles.   Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. The safety risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus.  Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with "I" on one side and "114" on the reverse. Losartan tablets are white and oval-shaped with the letter "I" imprinted on one side and the number "5" imprinted on the reverse.
Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma.  Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.
Guidance for Industry - Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases  This  guidance
 is intended for sponsors of drugs and biological products are considering submitting requests for orphan-drug designation for their drugs under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration (FDA) does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). Pediatric-subpopulation designations that have already been granted will not be affected by this change.
Guidance for Industry -Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations  This guidance
 is intended to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. It discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This guidance also is intended to help sponsors facilitate the timely conduct of clinical trials, reduce the use of animals with the 3R (reduce/refine/replace) principles, and reduce the use of drug development resources.

August 30
Invitation to Public Workshop - Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care  
When: Thursday, September 20, 2018 | 9:00 AM - 4:15 PM 
Where: National Press Club, 529 14th Street NW, Washington, DC 20045             
Event Agenda: here.
Objectives: 
  • Understanding opioid use disorder and the treatment armamentarium,
  • Effective approaches and models of care,
  • Barriers to access for treatment of opioid use disorder,
  • Opportunities and barriers to expand treatment for vulnerable populations, and
  • Defining success and identifying outcomes that matter for OUD treatment.
FDA Advises Consumers to Avoid Eating, Drinking, or Handling Food Products Prepared by Adding Liquid Nitrogen at the Point of Sale.  These products are often marketed under the names "Dragon's Breath," "Heaven's Breath," "nitro puff" and other similar names.  Liquid nitrogen, although non-toxic, can cause severe damage to skin and internal organs if mishandled or accidently ingested due to the extremely low temperatures it can maintain.    Read the full advisory

August 29
FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes  This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier's gangrene.   SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.  Patients should seek medical attention immediately if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.  Publications report that Fournier's gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years (3.3 out of 100,000)

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination.  This voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist is due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company's Florida facility. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. This recall should be carried out to the retail level.  Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals.

August 28
Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up.   A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling.  Accord is recalling this individual lot from the market.  Accord's Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.   Consumers/Pharmacies with questions regarding this recall can contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at rxrecalls@inmar.com Monday to Friday during business hours 8 am to 5 pm EST.

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children's Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle.  The reason is because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL). For more information control/click on:
FDA alerts consumers and pet owners not to use products manufactured by King Bio, including Dr. King's label, homeopathic drug and pet products.These products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has  expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.

The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.  The networks receiving warning letters include: CoinRXMedInc.bizPharmacyAffiliates.org and PharmaMedics.
August 27
FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs.  Today, the FDA issued a Federal Register notice proposing not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities
 may use in compounding under section 503B of the Federal Food, Drug & Cosmetic Act (503B bulks list).
CDER SBIA Webinar: Writing the Indications and Usage Section of Labeling: FDAs New Draft Guidance  Thursday, September 27, 2018, 1:30 p.m. to 2:30 p.m. EDT  Register Now  This webinar will provide insight on FDA's recommendations for the "Indications and Usage" section of labeling as outlined in the draft guidance Indications and Usage Section of Labeling for Human Prescription Drug Biological Products - Content and Format. Webinar participants will hear directly from the FDA on current recommendations for:  How to write, organize, and format the information in the "Indications and Usage" section;  General principles to consider when drafting the "Indications and Usage" section; and When to include limitations of use in the "Indications and Usage" section.

August 24
FDA Updates on Valsartan Recalls - Torrent Pharmaceuticals Limited is expanding its voluntary recall.  FDA has updated the  list of valsartan productsunder recall- Additional lots added!  To learn more, please visit: Valsartan Recalls.   The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

Guidance for Industry - Quality Attribute Considerations for Chewable Tablets Guidance for Industry   Download your copy by control/click on the colored title above.

August 23
The FDA, CDC, along with state and local officials are investigating a multi-state outbreak of cyclosporiasis illnesses likely linked to salads from McDonald'srestaurants.  As of August 23, 2018, a total of 507 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald's restaurants; the cases were reported by 15 states and New York City. The investigation is ongoing and the FDA is currently reviewing distribution and supplier information for romaine and carrots.  Read the full update

New Draft Guidance for Industry - Hematologic Malignancy and Oncologic Disease   The FDA is announcing the availability of a draft guidance for industry entitled "Hematologic Malignancy and Oncologic Disease:  Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development."  This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need.  Today, the U.S. Food and Drug Administration announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases. Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher (PRV). A tropical disease PRV can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review.  For more information, please visit: Tropical Disease Priority Review Voucher.
August 22
FDA approves new drug Oxervate (cenegermin) for neurotrophic keratitis, a rare eye disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).  Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation. The loss of corneal sensation impairs corneal health causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases. The prevalence of neurotrophic keratitis has been estimated to be less than five in 10,000 individuals.  For more information, please visit: Oxervate.
August 21
FDA's In-person or Online Event - Electronic Drug Registration and Listing Using CDER Direct on October 2, 2018 at Silver Spring, MD.    Registration and Agenda  This event is free to the public. You may attend in-person or via webcast.  
                  
Why Attend?  As the registration renewal and drug listing recertification period approaches, this event will educate and assist drug firms with the registration and listing process.  Experts and helpdesk technicians will be there in-person to answer regulatory and technical questions and assist with submissions.
                  
Who Should Attend?  Those who want to learn more about drug registration and/or listing with CDER Direct.  

Session HighlightsFDA will walk-through submissions and discuss the following:
Establishment Registration, Product Listing, Top 10 Errors, Compliance Cases,
Listing Recertification, Labeler Code Request, National Drug Code Reservation
DRLS Compliance Program, and 503B Product Reporting for Compounding Outsourcing Facilities
FDA has taken additional action to mitigate shortages of Mylan's EpiPen (epinephrine) auto-injector by extending expiration date 4 months for specific lots of medication. While the product is currently available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen's limited availability in certain areas in the U.S.  The agency also  recently approved the first generic version of EpiPen and EpiPen Jr to be manufactured by Teva Pharmaceuticals USA.  For more information, please visit: EpiPen FDA In Brief.
The US Food and Drug Administration (FDA) approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.   Diacomit is indicated for use in patients 2 years of age and older taking clobazam. There are no clinical data to support the use of DIACOMIT as monotherapy in D, ravet syndrome.   Dravet syndrome is a rare g, enetic condition that usually appears during the first year of l, ife with prolonged fever-related seizures (febrile seizures). Later, other types of seizures typically appear, including myoclonic seizures (involuntary, irregularly repetitive muscle jerks).  Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.  For more information, please visit: Diacomit.
August 20
New FDA Update on Valsartan Recalls: FDA updates recalled valsartan-containing product information and presents NDMA levels in some foods.  N-nitrosodimethylamine (NDMA) is a known environmental contaminant. For context, it is found in water and foods including meats, dairy products and vegetables.  Estimated Range of Daily NDMA Consumption for certain foods (Recommended daily food consumption rates based on Dietary Guidelines for Americans 2015-2020):   Cured meat - 0.004-0.23 micrograms,
Smoked meat - 0.004-1.02 micrograms, Grilled meat - 0.006-0.13 micrograms, and Bacon - 0.07-0.09 micrograms For more information please visit: Valsartan

The New Vaccine (Shingrix) for Shingles is 90% Effective.CDC recommends Shingrix (recombinant zoster vaccine), as the preferred vaccine, over Zostavax® (zoster vaccine live), a shingles vaccine in use since 2006. Healthy adults 50 years and older should get two doses of Shingrix, 2 to 6 months apart.  Ensure that two doses are administered to healthy adults 50 years and older within the recommended 2-6 month interval.  If more than 6 months have elapsed since the first dose, administer the second dose as soon as possible.  Do not restart the vaccine series, and do not substitute Zostavax (zoster vaccine live) in place of the second dose of Shingrix. This fact sheet Two (2) pages describes who should get the new shingles vaccine as well as the benefits and side effects.   More information appears on Shingrix Shingles Vaccination | What You Should Know | CDC  and better yet at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/shingles-recombinant.pdf
August 17
FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China and advises patients not to use porcine thyroid medicine labeled as Westminster.  FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients - levothyroxine and liothyronine - and should not be used to manufacture or compound drugs for patient use. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences. FDA placed Sichuan Friendly on  import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection. However, FDA confirmed Sichuan Friendly's thyroid API remains in the U.S. supply chain. This API and the drug products made from it, present a safety risk to patients. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices.  FDA recommends patients talk to their health care professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved.
FDA is extending the proposal period for the  Quality Metrics Site Visit Program.   The program was announced in the Federal Register on June 29, 2018. Interested stakeholders were originally given until August 28, 2018 to submit a proposal. Due to the interest in the program, the proposal period is being extended to December 17, 2018.  The Quality Metrics Site Visit Program is designed to offer experiential and firsthand learning opportunities to FDA staff involved in development of FDA's Quality Metrics Program. Staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing FDA's Quality Metrics Program. FDA staff will also observe how quality metrics data are gathered, collected, and reported to management. The intended timeframe of the on-location Quality Metrics site visits is from October 1, 2018 to September 30, 2019. The end date may be change based on interest and resources.  For additional information, visit FDA's quality metrics webpage or our recent FDA Voice blog post on quality metrics.
August 16
Zakah Life, LLC of Ankeny, Iowa, is recalling Kratom products.  Specifically Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
August 15
Prescription Drug User Fee Amendments          Fiscal Year 2019 fee rates:

User Fee Type                                                2019                                    2018
Application Fee - Clinical Data Required      $2,588,478                       $2,421,495
Application Fee - No Clinical Data Require   $1,294,239                       $1,210,748
Program Fee                                                  $309,915                          $304,162
Full payment of the invoice is due October 1, 2018
August 13
The following drug contain hidden drug ingredients:  Nuvitra, XXXPlosion Ultra, Panther Power Platinum, Ding Ji Wei Ge, and 5K 


August 10

August 10
Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level.   This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit - I (API manufacturer).

FDA is announcing the availability of a draft guidance for industry entitled " Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics."  The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of FIH clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs.

August 8
Guidance for Industry -  Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB)   Download your copy by Control/Click in the colored title.  This guidance finalizes the guidance for industry issued in August 2015 entitled "Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs".  This guidance also clarifies the recommendations in the guidance for industry on  Dissolution Testing of Immediate Release Solid Oral Dosage Forms for certain high solubility drug substances in IR drug products. 
FDA has launched a new Medication Guide database to replace the current Medication Guide web page.   Medication guides are provided with many prescription medicines.  You can view the new medication guide database here.
The FDA is holding a public hearing regarding the future format of the  National Drug Code (NDC). An NDC is a unique 10-digit, 3-segment identifier which is assigned to all drugs in U.S. commercial distribution. An NDC is proposed by companies and assigned by FDA through the drug listing process. Current formats for the NDC sequence are 4-4-2, 5-4-1 and 5-3-2.  FDA recognizes the importance of the NDC in many aspects of health care today and is aware that any change to its format or length will have an impact on the health system. Recognizing that a change to NDC length and/or format will be necessary when FDA runs out of 5-digit labeler codes, FDA is holding this public hearing to receive input from stakeholders on how to maximize the benefit and minimize this impact well in advance of any forthcoming change.  The hearing will be held on November 5, 2018, in Silver Spring, Md.  Control/Click on colored words for more information.
August 7
Guidance for Industry -   Elemental Impurities in Drug Products.   This final guidance provides recommendations for controlling elemental impurities consistent with the ICH Q3D guideline and USP requirements.
August 6
The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of E. coli O157:H7 illnesses linked to romaine lettuce from the Yuma growing region.  As FDA has previously stated, samples of canal water have tested positive for the outbreak strain of E. coli. FDA continues to consider that contaminated water coming into contact with produce, either through direct irrigation or other means, is a viable explanation for the pattern of contamination.Read the full update

August 3

Specialty Pharma Industry News (July 2018)
July 30
FDA approves first treatment for rare adrenal tumors.   The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use. The FDA granted the approval of Azedra to Progenics Pharmaceuticals, Inc.  Their application was granted Fast TrackBreakthrough Therapy and Priority Review designations. Azedra also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA is announcing the rates for biosimilar user fees for fiscal year (FY) 2019.    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application.  These fees apply to the period from October 1, 2018, through September 30, 2019.  This Federal Register Notice provides updated BsUFA fee information for industry. 
July 27
New FDA Update on Valsartan Recalls: FDA updates both lists of products included in the recall and the list of products NOT included in the recall.  The following additional repackagers are recalling or are expected to recall valsartan-containing products.  FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:  Bryant Ranch Prepack Inc.; H. J. Harkins Company Inc. (this company was not originally included on either list); Lake Erie Medical, doing business as Quality Care Products LLC; NuCare Pharmaceuticals Inc.; Northwind Pharmaceuticals; and Proficient Rx.
July 26
FDA Investigates Multistate Outbreak of Cyclospora Illnesses Likely Linked to Salads from Fast Food Chain.  The FDA, CDC, along with state and local officials are investigating a multi-state outbreak of cyclosporiasis illnesses likely linked to salads from McDonald's restaurants.  The CDC reports that 286 people in 15 states have become ill. There have been 11 hospitalizations and no deaths.  FDA, CDC, state, and local partners are currently investigating several Cyclospora illnesses associated with McDonald's locations in IA, IL, IN, KY, MN, MO, NE, OH, SD, and WI.

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported.  The following four varieties with the indicated codes are subject to this recall:  Flavor  Blasted ® Xtra Cheddar, FlavorBlasted ® Sour Cream & Onion, Goldfish ® Baked with Whole Grain Xtra Cheddar, and Goldfish ® Mix Xtra Cheddar + Pretzel.

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.  As of July 24, 2018, CDC reports that there were 77 cases in nine states with 36 hospitalizations. Illnesses occurred from April 30, 2018, to July 2, 2018. Ill people ranged in age from less than 1 year to 97, with a median age of 67. Sixty-seven percent were female. Out of 70 people with information available, 36 (51%) were hospitalized. No deaths were reported.  As of July 26, 2018, CDC reports this outbreak appears to be over.

July 24
Warning Letters 
  1. Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC
Products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated.

      2.  Milbar Laboratories, Inc., East Haven, CT
a. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

b. Your firm failed to reject any lot of components that did not meet the appropriate written specification for identity, strength, quality, and purity.
c.  Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
d.  Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
        3.   Yuki Gosei Kogyo Co.,  Ltd.,  Chuo-Ku, Tokyo, Japan
Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.
 4.   GC Natural, Irvine, CA
a.  Drug Products:  The claims on your website and your product labels establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
b.  Dietary Supplements:  You did not establish written procedures for the responsibilities of the quality control operations.
c.  Dietary Supplements:   You failed to establish specifications for dietary supplement labels (label specifications).
d. Dietary Supplements:You failed to establish and follow written procedures for holding operations.
e. Dietary Supplements:Your written procedure titled "Returns Policy" does not include all required information for identifying and quarantining returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.
f.  Dietary Supplements: Your written procedure titled "Complaint Handling Procedure" does not include the following requirements related to the review and investigation of product complaints.

  5.  BioDiagnostic International, Irvine, CA

a.  During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. A large metal roll-up door at the entrance to your facility was open to the outdoors, while an open pot you use as a mixing vessel contained in-process material and was not covered. The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.

b.  Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups.

c.  Your firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary.

d.  Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

e.  Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products .
FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients. As part of its ongoing implementation of the  Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the U.S. Food and Drug Administration is announcing several actions to protect public health related to the compounding of human drug products.

a.  Today, the FDA issued a  compounding risk alert to warn health care providers, compounders and patients of the dangers of using the bulk drug substance cesium chloride.

b.  The FDA is collaborating with the University of Maryland and Johns Hopkins University, two of the agency's Center of Excellence in Regulatory Science and Innovation (CERSI) partners, to gather and analyze information important for developing the list of bulk drug substances that may be used in compounding
c.  The FDA is currently updating the categories of substances that are subject to its interim policies on compounding with bulk drug substances.

d.  To continue to seek public input on its policies around compounding, the ninth Pharmacy Compounding Advisory Committee meeting is  scheduled for September 12, 2018 . The committee will discuss six bulk drug substances that were nominated for use in compounding by 503A facilities: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride and quercetin dihydrate.

To learn more control/click on the colored phrases in the above news item.
July 20
FDA seeks input on product-specific guidances to facilitate generic drug development.  FDA has published 43 product-specific guidances, including 26 new guidances and 17 revised guidances, that, when finalized, will describe the Agency's current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. For more information and to view the guidances, visit:
July 18
FDA Releases Final Guidance for Industry: "Labeling for Biosimilar Products."  Today, FDA finalized the guidance for industry "Labeling for Biosimilar Products." This guidance provides an overview of FDA's recommendations for biosimilar product labeling and is intended to assist industry in developing labeling for submission in proposed biosimilar product applications.   A biosimilar product is a biological product that is approved based on a demonstration that it is highly s, imilar to an FDA-approved biological product, known as a reference product.  Biosimilar products create competition and can improve access and lower the costs to patients of important treatments.

July 17
Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen. As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.  
                  
The cause was due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical.  The impurity detected in the API is N- nitrosodimethylamine which has been classified as a probable human carcinogen as per International Agency for Research on Cancer,
Control/Click on the following to read more: 
 
New Draft Guidances: Innovative Approaches for Nonprescription Drugs/ Indications & Usage Section of Labeling / Studies of Drugs to Treat Patients on Multiple Antihypertensive Drugs.  Just left click on the colored words below to download the guidance.
  1. Innovative Approaches for Nonprescription Drug Products.  This guidance  describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product.
  2. Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products - Content and Format.  This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling.
  3. Hypertension: Conducting Studies of Drugs to Treat Patients on Background of Multiple Antihypertensive Drugs.  This guidance is intended to clarify the recommended approach for sponsors developing drugs to treat hypertension for patients who are on a background of multiple antihypertensive drugs. 
Wearable mHealth Device (Zio Patch) Detects Abnormal Heart Rhythms (AFib) Earlier  As many as 6 million Americans experience a common type of irregular heartbeat, called atrial fibrillation (AFib) that can greatly increase their risk of stroke and heart failure [1]. There are several things that can be done to lower that risk, but the problem is that a lot of folks have no clue that their heart's rhythm is out of whack!  Control/Click on: Read more... 
July 13
FDA approves the first drug with an indication for treatment of smallpox. The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.  Prior to its eradication in 1980, variola virus, the virus that causes smallpox, was mainly spread by direct contact between people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache and backache. A rash initially consisting of small, pink bumps progressed to pus-filled sores before finally crusting over and scarring. Complications of smallpox could include encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye) and blindness. TPOXX's effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox, and was based on measuring survival at the end of the studies. More animals treated with TPOXX lived compared to the animals treated with placebo. 
FDA Advises Consumers to Avoid Potentially Contaminated Fresh Crab Meat Imported from Venezuela due to Vibrio parahaemolyticus.   Consumers are advised to ask where their crab meat is from, if dining out at a restaurant or in grocery stores. This product is commonly found in plastic tubs and may be labeled as "pre-cooked." As this is an ongoing investigation, the FDA will share additional updates as soon as information becomes available. The FDA and the states are conducting an investigation to determine the source of contaminated fresh crab meat and ensure it is removed from the food supply. Retailers should not serve or sell fresh crab meat imported from Venezuela. The states reporting cases associated with this outbreak include  Maryland (8), Louisiana (2), Pennsylvania (1), and the District of Columbia (1).
FDA warns of imposters sending consumers fake warning letters to target individuals who tried to purchase medicines online or over the phone.  Apparently, these fake warning letters are linked to an international extortion scam. The FDA generally does not issue warning letters to individuals who purchase medicines online. The letters also warn consumers that "we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end."  Any consumers who believe they may have received a fake warning letter should email FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov with as much information as possible about the letter and its packaging, including sending photos or scanned documents to help aid in the FDA's ongoing investigation of the scam.

July 12
FDA is Investigating Multistate Outbreak of Salmonella Mbandaka Infections Linked to Kellogg's Honey Smacks Cereal.  The FDA has become aware that recalled Kellogg's Honey Smacks cereal are still being offered for sale. All Honey Smacks cereal was recalled in June 2018.  Retailers cannot legally offer the cereal for sale and consumers should not purchase Kellogg's Honey Smacks cereal.

July 11
The U.S. Food and Drug Administration is proposing to revise the front of pack (FOP) type size labeling requirement for packaged foods sold in glass-front vending machines.The proposed change would apply only to calorie declarations on the front of packages that consumers can view through the glass before deciding which foods to purchase. Some industry representatives voiced concerns that the current requirements for type size, established in the FDA's 2014 final rule on calorie labeling for foods sold from vending machines, would make the calorie labeling size fluctuate widely and created technical challenges that could make it difficult to comply with the regulation. 

July 10
FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier's Compounding Laboratory (dba Ranier's Pharmacy).  During FDA's recent follow-up inspection of Ranier's compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company's ability to assure the sterility of its drug products.
New FDA Drug Safety Communication for fluoroquinolone antibiotics The Food and Drug Administration (FDA) is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. The low blood sugar levels can result in serious problems, including coma, particularly in older people and patients with diabetes who are taking medicines to reduce blood sugar. We are making these changes because our recent review found reports of life-threatening low blood sugar side effects and reports of additional mental health side effects.  Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems. 
CDER SBIA Chronicles: The FDA Adverse Event Reporting System (FAERS) Public Dashboard and its Value to the Pharmaceutical Industry   To print your click this link.
July 9
The following products have hidden drug ingredients:
Grakcu Capsule contains hidden drug ingredients     (sildenafil and tadalafil)
C.U. Plus contains hidden drug ingredients      (sildenafil and tadalafil)
 Dale Mas contains hidden drug ingredients      (sildenafil and tadalafil)
 Asunsa contains hidden drug ingredients     (N-desmethylsibutramine and benzylsibutramine are substances structurally similar to sibutramine)
 Lyn DTOX FS3 contains hidden drug ingredients   (sibutramine and N-desmethylsibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. N-desmethylsibutramine is a substance structurally similar to sibutramine.)
July 5
FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination.   
FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa.  Blissful Remedies announced a recall on June 30, 2018. FDA is concerned this recall does not include all products.
July 3

Specialty Pharma Industry News (June 2018)
June 29
FDA advises health care professionals not to use MedGyn Products' Monsel's Solution (ferric subsulfate 20%). This drug product was made under poor conditions. The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois.

June 28
FDA Approves Labeling Supplement for Celebrex (celecoxib - a COX-2 selective non-steroidal anti-inflammatory drug (NSAID).  The labeling supplementwill include results from a postmarketing cardiovascular outcomes trial that found that at the lowest dose, Celebrex was similar to moderate doses of naproxen and ibuprofen with regard to cardiovascular (CV) safety. The results of the PRECISION trial demonstrated that celecoxib at the lowest approved dose of 100 mg twice daily, is non-inferior to (or no worse than) ibuprofen dosed in the range of 600 mg - 800 mg three times daily or naproxen dosed in the range of 375 mg - 500 mg twice daily on a composite cardiovascular endpoint consisting of cardiovascular death, nonfatal myocardial infarction ("heart attack," or MI), and nonfatal stroke.

FDA Investigating Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce from Yuma Growing Region.  To date, CDC analysis of samples taken from canal water in the region has identified the presence of E. coli 0157:H7 with the same genetic finger print as the outbreak strain.   Suspect product is no longer being harvested or distributed from this area and is no longer available in stores or restaurants, due to its 21-day shelf life.
FDA is announcing two new programs to gather feedback on the use of quality metrics self-reporting program to modernize pharmaceutical quality systems and advance innovation.

  1. Quality Metrics Feedback Program:
A. FDA is encouraging new drug application holders to request  Type C Formal Meetings and abbreviated new drug application (ANDA) holders to submit pre-ANDA meeting requests to FDA to initiate discussions on quality metrics for specific products.

B. FDA is also initiating a pilot study to gain feedback from other types of establishments, including active pharmaceutical ingredients (API) establishments, contract manufacturing organizations (CMOs), over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments.

A. This voluntary site visit program is designed to offer experiential and firsthand learning opportunities to FDA staff involved in development of FDA's Quality Metrics Program. 
B.  Staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing FDA's Quality Metrics Program.  FDA staff will also observe how quality metrics data are gathered, collected, and reported to management. 

Warning Letters Update (abbreviated summary findings)
1)   Sichuan Friendly Pharmaceutical Co., Ltd., Sichuan Province, (southwest) China
a) Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
b) Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
c) Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.
d) Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to have adequate controls to prevent omission of data.
2)   Henan Lihua Pharmaceutical Co., Ltd., Anyang, Henan, China
a) Failure of your quality unit to review and approve all appropriate quality-related documents.
b) Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.

June 26
FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The U.S. Food and Drug Administration (FDA) published an update to the "List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic ." The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. Both  PDF and  Excel formats are available. Control/Click on the colored lettering above to obtain your list.
June 25
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. 
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.  CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the "high") that comes from tetrahydrocannabinol (THC).

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry Download your copy with a Control/Click on the heading in this paragraph.
June 22
Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration ("FDA") via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines. These products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

June 21
FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.  The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.  The FDA continues to encourage sponsors of proposed biosimilar products to discuss product development plans with the agency, including the evaluation of analytical data intended to support a demonstration that the proposed biosimilar product is highly similar to a reference product.  The FDA will continue to provide development-stage advice to sponsors of proposed biosimilar products or proposed interchangeable products through several types of formal meetings, which are described in more detail in FDA's guidance for industry,  Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.  More information about this and other FDA guidance documents related to biosimilar products and interchangeable products, as well as contact information for FDA, is available at  http://www.fda.gov/biosimilars. The FDA will communicate publicly when new draft guidance is issued in relation to the evaluation of analytical data between a proposed biosimilar product and a reference product.

June 20
FDA publishes draft guidance on major depressive disorder. Today the U.S. Food and Drug Administration published a concise guidance that highlights current advice to sponsors for clinical development of drugs for the treatment of major depressive disorder (MDD). Specifically, this guidance addresses the FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. The guidance:
  • Includes advice for rapid-acting antidepressant development programs that covers     nonclinical and clinical pharmacology studies, and clinical trial design features unique to this class of products,
  • Addresses the distinction between partial response and treatment-resistance, both in terms of study designs and potential labelling claims, and
  • Clarifies the pediatric study requirements, describing relevant age groups and noting that extrapolation of efficacy from adult studies is not acceptable.
New Webinar: FDA's Overview of the Regulatory Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US.  FDA is launching a webinar titled, "FDA's Overview of the Regulatory Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US".  Dr. Sue Lim, M.D., Director of the Scientific Staff, Therapeutic Biologics and Biosimilars Team, CDER, FDA presents information on the regulation and development process of biosimilar and interchangeable products. This presentation was recorded to help FDA Advisory Committee members and Special Government Employees gain useful insight into the unique regulatory features and key concepts about biosimilarity and interchangeability.  To view this presentation visit our webinar, presentations, and articles page at  www.fda.gov/biosimilars. 
 
June 19 
FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre- Cut Melons.  As of June 19, 2018, CDC reports that there are now 70 cases in seven states with 34 hospitalizations. Illnesses occurred from April 30, 2018, to June 3, 2018. Ill people range in age from less than 1 year to 97, with a median age of 67. Sixty-seven percent are female. Out of 63 people with information available, 34 (54%) have been hospitalized. No deaths have been reported.  FDA advises consumers not to eat recalled fresh cut watermelon, honeydew melon, cantaloupe, and fresh-cut fruit medley products containing any of these melons. Products have been distributed in Alabama, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Virginia, West Virginia, and Wisconsin. The products were packaged in clear, plastic clamshell containers under several different brands or labels and distributed to Costco, Jay C, Kroger, Payless, Owen's, Sprouts, Trader Joe's, Walgreens, Walmart, Whole Foods/Amazon. Other retail locations may be added to the list.
June 15
The FDA is advising consumers to not eat and to discard any Kellogg's Honey Smacks cereal.  The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg's Honey Smacks cereal   The FDA is advising consumers to not eat and to discard any Kellogg's Honey Smacks cereal. This is regardless of size or "best if used by" dates. The recall notice accounts for the entire product that is on the market within the cereal's estimated one year shelf-life. However, Honey Smacks products with earlier dates could also potentially be contaminated.
 
FDA approves first generic versions of Suboxone (buprenorphine and naloxone sublingual film applied under the tongue) for the treatment of opioid dependence. Adverse events commonly observed with the buprenorphine and naloxone sublingual film areoral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema (accumulation of fluid causing swelling in lower limbs).

June 13
FDA Notification Regarding Isometheptene-Containing Drug Products  FDA notified manufacturers and labelers (see list below) on October 12, 2017, to stop distributing their isometheptene mucate-containing drug products (containing either isometheptene mucate, dichloralphenazone, and acetaminophen or isometheptene mucate, caffeine, and acetaminophen). As of January 1, 2018, all of these companies agreed to cease distribution of the unapproved isometheptene-containing drugs.  FDA considers isometheptene-containing drug products unapproved new drugs that cannot be distributed in interstate commerce without a new drug application approved by FDA. The distribution of any unapproved isometheptene-containing drug product, not limited to the drug products listed below, is considered to be marketed unlawfully and subject to enforcement action.
FDA issues two new final guidances that provides firms with greater clarity on medical product communications The first guidance, "Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities-Questions and Answers," answers common questions about companies' communications to payors, including insurance companies, formulary committees and similar entities. It recognizes that payors seek a range of information on the effectiveness, safety and cost-effectiveness of approved/cleared medical products, including information from pharmaceutical manufacturers, to help support product selection, formulary management and/or coverage and reimbursement decisions.
The second guidance, " Medical Product Communications That Are Consistent With the FDA-Required Labeling," provides the FDA's views on manufacturers' communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling. Control/Click on the colored titles above to read the entire document.

June 12
The U.S. Food and Drug Administration issued  Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other StakeholdersThis draft guidance is the first in a series, and specifically addresses questions such as "Whom do you get input from, and why? How do you collect the information?" It discusses sampling methods that could be used when planning to collect patient input. It also provides a general overview of how the relationship between potential research question(s) and method(s) need to be considered when deciding from whom to get input (including defining the target population and development of the sampling strategy). This draft guidance also includes a glossary of terms that will be used in this and one or more future guidances.
FDA is announcing the availability of a draft guidance for industry entitled "  
This guidance provides this information and is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway.  This guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h) of the FD&C Act, added by section 3042 of the Cures Act.

June 11
FDA Announces Availability of a Final Guidance, Bioanalytical Method Validation This guidance, entitled "Bioanalytical Method Validation", incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods.  The guidance addresses validating bioanalytical methods used in human clinical pharmacology, bioavailability, and bioequivalence studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation. Control/Click on colored title above to view guidance.

June 8
PAYA Dietary Supplement Product contains hidden drug ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use PAYA Dietary Supplement Product, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.  FDA laboratory analysis confirmed that PAYA Dietary Supplement Product contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.
June 5
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales.  Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction.  Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act.
June 4
Proposed Modernization of FDA's Drug Review Office   FDA has proposed an important series of new steps to modernize the organization and functions of CDER's Office of New Drugs. These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities. The proposals include regulatory and review process changes, as well as organizational restructuring. We also intend to strengthen the support structures, including personnel and Information Technology (IT), that underpin the regulatory process.
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.  The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
FDA launches improvements to the  FDA’s Adverse Event Reporting System (FAERS) dashboard.The changes encompass a wide-range of items, such as enabling the selection of multiple products for a search and the downloading of search results, as well as enhancing display formats so more information is shown in one screen.  For more information on using the FAERS dashboard please see the  FAERS webinar and the  FAERS dashboard FAQ page.  Again, Control/Click on the colored titles for more information.

June 1
Apotex Corp.  Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles  Apotex Corp. is voluntarily recalling one (1) lot (NJ4501) of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.  There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.
Guidance for Industry - Complicated Urinary Tract Infections: Developing Drugs for Treatment  Download your copy here.

Specialty Pharma Industry News (May 2018)
May 30
Warning Letters Update   (abbreviated summary findings)

1.     Biologique Recherche (B.R.) SAS,  Surenes, France

a)    Your firm failed to have laboratory determination of the identity and strength of each    active ingredient prior to release.
b)    Your firm failed to establish the reliability of component supplier analyses through appropriate validation of the supplier's test results.
c)     Your firm failed to establish written responsibilities of the quality control unit. Your firm failed to establish, through a testing program, the stability characteristics of drug products to determine expiry dates.
2.   Taiwan Biotech Company, Ltd., Taoyuan City, Taiwan R.O.C.
a)     Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
b)    Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products.
c)     Your firm failed to maintain written records (aka Annual Product Reviews) that could be used for evaluating the quality standards of each product  to determine the need for changes in drug product specifications or control procedures.

3.    IDT Australia Ltd., Boronia, Victoria, Australia
a)     Failed to adequately investigate out-of-specification results and implement appropriate corrective actions.
b)    Failure of your quality unit to ensure that critical deviations are investigated and resolved.
c)     Your firm failed to establish and follow adequate required laboratory control mechanisms, including any changes made by them which were drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
d)    Your firm failed to ensure that all laboratory records included complete data to assure compliance with established specifications and standards.
Your firm failed to establish an adequate quality control unit.
4.    Europharma Concepts Limited, Tullamore County, Offaly, Ireland
a)     Your firm failed to test samples of each components for conformity with all specifications for identity, purity, strength, and quality.
b)    Your firm failed to establish adequate written procedures to assure that the drug products you manufacture have the identity, purity, strength, and quality they purport or are represented to possess.  Your firm's Quality Control Unit did not review and approve procedures including any changes.

5.    Kolmar Korea Co. Ltd., Sejong-si, Republic of Korea (South)
a)     Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
b)    Your firm failed to follow written procedures applicable to the quality control unit.

6.    Jalco Cosmetics Pty. Ltd., Silverwater, Australia
a)     Your firm failed to have appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including identity and strength of each active ingredient, prior to release.
b)    Your firm failed to test samples of each component for conformity to specifications.
c)     Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture conform to specifications.
d)    Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products.
7.   Jilin Shulan Synthetic Pharmaceutical Co. Ltd., Shulan City, China
a)     Failure to document known deviations and out-of-specification results and conduct a thorough investigation.
b)    Failure to prevent unauthorized access, changes to data or omission of data from computerized systems.
c)     Failure to record activities at the time they are performed.

8.   Reine Lifescience, Gujarat, India
       a)   Failure to validate and verify the suitability of analytical methods.
b)   Failure to prevent unauthorized access, changes to data or omission of data from computerized systems.
c)   Failure to adequately validate written procedures for the cleaning and maintenance of equipment.

9.   Goran Pharma Private Limited, Gujarat, India
a)   Your firm failed to ensure the identity of components, including your active ingredients and excipients from various suppliers.
b)   Your firm failed to establish an adequate quality control unit with the responsibility to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products
c)   Your firm failed to use production equipment of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
d)   Your firm failed to provide equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature when appropriate for the manufacture, processing, packing, or holding of a drug product.       

10. Degasa S.A. De C.V., Morelos, Mexico    
a)   Your firm does not have, for each batch of drug product, appropriate laboratory testing, of each batch of drug product required to be free of objectionable micro-organisms.
b)   Your firm failed to ensure that laboratory records included completed data from all      tests necessary to assure compliance with established specifications and standards.

May 29
Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules.  TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, are indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.  As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. 

May 24
FDA urges manufacturers to stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years.  The FDA is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.  Due to the significant safety risk of methemoglobinemia, we have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market. 
 
May 22
Guidance for Industry:   Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application. Obtain your copy by Control/Click on the colored print above.

Guidance for Industry: Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment The purpose of this guidance is to provide recommendations to industry for establishing clinical effectiveness of drugs for the treatment of acne vulgaris (acne). The recommendations in this guidance are based on the FDA's assessment of issues raised in the review of clinical trials for acne. Control/Click on the colored word above to obtain your copy.

FDA Issues Final Guidance for Industry on Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax. 
FDA is announcing the availability of a guidance for industry entitled Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax. The purpose of this guidance is to assist sponsors in the development of new drugs to be administered to people who have or may have inhaled Bacillus anthracis spores, but who have not yet manifested clinical evidence of disease, to prevent the development of inhalational anthrax. This guidance clarifies that drugs for the prophylaxis of inhalational anthrax are to be considered for approval under the animal rule regulations because human efficacy trials are not ethical or feasible.  This guidance finalizes the draft guidance of the same name issued on February 16, 2016.
 
Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk. Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product ("Product") because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals.   Ethanol Extraction's Product was sold through the company's website -- ethanolextraction.com --and delivered by direct shipment throughout the U.S.  The Product was sold in various size plastic bottles, ranging from 8 oz to 1 gallon, as well as 2.5 gallon and 5 gallon containers.  The Product was first sold in October 2016 and last sold on April 30, 2018. The Product's intended use is as a solvent for extracting essential oils from plant material, and contains warnings including "HARMFUL IF SWALLOWED.   MAY CAUSE DAMAGE TO ORGANS." The Product is not for human or animal consumption.

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment, and other medical uses.  The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products -  Front Range Kratom of Aurora, Colorado;  Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri - for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.  The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.  The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom's safety profile, including the use of kratom combined with other drugs.Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and treat other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.
Mediterranean diet may slow development of Alzheimer's disease.   
A Mediterranean diet is high in foods such as fruits, vegetables, and lean protein. In contrast, a standard Western diet contains an excess of red meat, saturated fats, and refined sugar. The differences that the research team found may signal early Alzheimer's disease.  The brain scans taken at the beginning showed that the people who ate a Western diet already had more beta-amyloid deposits than those who ate a Mediterranean diet. Beta-amyloid is a protein known to collect in the brains of people with Alzheimer's disease. The brains of those who ate a Western diet also showed lower energy use-a sign of brain activity-at the beginning of the study than those who ate a Mediterranean diet. Both these differences suggest the early development of dementia. In the follow-up scans, people in the Western diet group showed even greater beta-amyloid deposits and reductions in energy use than the Mediterranean diet group. Factors such as age, sex, and a gene linked to Alzheimer's risk didn't account for the differences.  If your diet isn't balanced, you really need to make an effort to fix it, if not for your body, then for your brain."

FDA Releases Final Guidance on Bioanalytical Validation.  
This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods.  The final guidance can be located here:  Bioanalytical Method Validation.
May 21
FDA approves new drug for patients with chronic liver disease.  The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.  For more information, please visit: Doptelet

May 18
MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir.  The drug products have been found to be manufactured with a lack of adequate controls.  Use of these products could result in an adverse reaction, especially in vulnerable populations such as infants and children.  These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil   Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). The presence of Sildenafil and Tadalafil renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
FDA approves new drug for preventive treatment of migraine in adults.  The U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.  People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.
May 17
FDA has published a list of inquiries from prospective generic drug applicants about Referenced Listed Drug access. FDA has received numerous inquiries from prospective generic applicants indicating that they are interested in developing a generic version of a drug product, but are unable to obtain samples of the reference listed drug (RLD) necessary to support their applications because of limitations on distribution of the RLD. These inquiries involve both drug products that are subject to Risk Evaluation and Mitigation Strategies (REMS) impacting distribution and products that are not subject to a REMS impacting distribution, but for which RLD sponsors have imposed voluntary distribution restrictions. To provide transparency regarding these inquiries, the agency has published  a list of all drug products about which FDA has received these kinds of inquiries related to RLD access, along with details including the name of the applicable RLD sponsor, the number of RLD access inquiries FDA has received about the product, and whether FDA has communicated directly to the RLD sponsor at the generic company's request (as further explained on the website itself, such a communication is voluntary and is only an option for certain products). FDA will update this list on a semi-annual basis. The agency published this list as part of the  Drug Competition Action Plan, which seeks to expand access to safe, high quality, effective generic medicines that can help consumers lower their health care costs.

May 15
Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency.
The decreased potency of Piperacillin and Tazobactam could result in worsening of the infection under treatment and under extreme circumstances lead to serious morbidities depending upon the severity of the illness. Elevated levels of impurities may result in various toxicities, such as liver, renal, and hematological toxicities.
May 14
Best Candy contains hidden drug ingredient.   This product was identified during an examination of imported goods.  FDA laboratory analysis confirmed that Best Candy contains nortadalafil. Nortadalafil is structurally similar to tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

May 11
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients.  The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.  Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS.  The most common side effects were headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities.
FDA is announcing the availability of a draft guidance for industry entitled "Pediatric HIV Infection: Drug Development for Treatment.
This draft guidance provides general recommendations on the development of products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age), including recommendations on when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection.  Control/Click on the colored title above to download your copy.
 
May 10

May 7
Guidance for Industry - Menu Labeling Supplemental Guidance This guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments,* including expanded and new examples of alternatives to aid in compliance.  Get your copy here.
  
Guidance for Industry - Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry Control/Click on the colored title above to download your copy.
Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 Kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.  Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever.  
 
May 3
FDA Extends Nutrition Facts Label Compliance Dates.   The U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply - until January 1, 2021. The agency published a proposed rule to extend the compliance date in September 2017, and this rule finalizes that extension.
Guidance for Industry
Assessing User Fees under the Prescription Drug User Fee Amendments of 2017 Download your copy here.
May 1
FDA Advises Consumers & Retailers to Avoid Potentially Contaminated (Norovirus) Raw Oysters from Canada. Oysters can cause food-related illness if eaten raw, particularly in people with reaction that excessively activates the body's infection-fighting immune system. This can cause severe inflammation throughout the body and lead compromised immune systems. Food contaminated with noroviruses may look, smell, and taste normal. Contaminated oysters were distributed to CA, IL, MA, and WA. It is possible that additional states received these oysters either directly from Canada or through further distribution within the U.S.

FDA Drug Safety Podcast:  FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal). FDA is warning that the medicine lamotrigine (brand name Lamictal) for seizures and bipolar disorder can cause a rare but very serious to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

Specialty Pharma Industry News (April 2018)


April 30
May 5, 2018, is the compliance date for submitting many types of files to the Food and Drug Administration in the electronic Common Technical Document (eCTD) format.  
While the Food and Drug Administration (FDA) recently announced that it is extending the compliance date for submitting Type III drug master files (DMFs) in electronic common technical document (eCTD) format by one year to May 5, 2019, other eCTD deadlines remain unchanged. FDA is encouraging sponsors to make sure they are submitting DMFs (other than Type III DMFs) and Commercial INDs in the eCTD format by May 5, 2018. Files not submitted in eCTD after May 5, 2018, will be rejected. 
The requirement to submit DMFs using the eCTD format is part of FDA’s overall effort to more efficiently review drug applications. eCTD standardizes how industry submits applications, amendments, supplements, and reports. The FDA has a number of resources to help submitters understand eCTD format and how to submit using eCTD:
April 27
Advancing the Science of Nanotechnology in Drug Development    Drug products containing nanomaterials are unique in several ways because they may take on different chemical, physical, or biological properties compared to other types of drugs. In some instances, this may impact the quality, safety, or efficacy of the product. For example, drug products containing nanomaterials may follow a different pathway in the body compared to a small molecule drug. After a drug product formulated as a nanomaterial enters the bloodstream, it could interact with specialized immune cells called macrophages, which engulf and transport a drug to the location for which it has been programmed, such as where bacteria, fungi, or viruses reside. These areas are typically difficult to reach for a small molecule.  For more information, please visit: Advancing the Science of Nanotechnology in Drug Development.

April 26
Guidance for Industry - Clinical Trial Imaging Endpoint Process Standards.  Download your copy here.

April 25
FDA Warns of Serious Immune System Reaction with Seizure and Mental Health Medicine Iamotrigine (Lamictal).  Lamictal used for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. Lamotrigine has been approved and on the market for 24 years, and is available under the brand name Lamictal and as generics.

Warning Letter 
Navid Vahedi, Owner Fusion IV Pharmaceuticals dba Axia Pharmaceutical, Los Angeles, CA   During our inspection in March 2018, investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigators noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.

April 24
Join FDA on July 9 for a Patient-Focused Drug Development Meeting for Chronic Pain at Its White Oak Campus in Maryland.  FDA is interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies. Please register early to attend the meeting in person or view the live webcast. For more information, please visit: Patient-Focused Drug Development.
 
April 23
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers  The FDA is announcing the availability of a final guidance entitled “ Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients:  Questions and Answers.” The guidance, which was prepared under the auspices of the  International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), addresses questions about implementation of FDA’s guidance on good manufacturing practice for active pharmaceutical ingredients (APIs) (ICH Q7).  The Q&A guidance is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess. To obtain your copy Control/Click on the colored print in quotes above.
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals; Draft Guidance for Industry   The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate program of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs).   

April 20
FDA takes new steps to advance the development of innovative products for treating opioid use disorder.  The U.S. Food and Drug Administration announced today the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. The first guidance, released today, explains the FDA’s current thinking about drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (i.e., modified-release products for injection or implantation).

CDER Drug Safety Priorities 2017 Report.    This annual review highlights new CDER initiatives and key safety-related milestones of 2017. Among many other efforts, the report focuses on CDER’s drug safety surveillance programs, safety oversight for generic drugs, new tools and approaches for fighting the opioid crisis, and our actions to help reduce preventable harm from medications. 

FDA’s Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders - May 10th FDA Grand Rounds  This 45-minute presentation is followed by questions from the audience.  Thursday, May 10, 2018,  12:00 p.m. - 1:00 p.m. EST,   Register here for webcast.

April 19
Viable Solutions, LLC Recalls Certain Kratom-Containing Powder Products Because of Possible Health Risk   The potentially affected powder products are packaged in kraft paper, foil-lined heat sealed pouches and sold in 25 grams, 100 grams, 250 grams, and 100 grams sizes. For more information Control/Click on:  
Viable Solutions, LLC Recalls Certain Kratom-Containing Powder Products Because of Possible Health Risk

Club 13 Recalls KratomMaeng Da Red Powder and Capsules Because of Possible Health Risk.  Club 13 of St. Augustine, FL is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of "Maeng Da Red" kratom powder; and 5-count, 25-count, 50-count, 100-count, 120-count capsule, and all bulk capsule orders of “Maeng Da Red” kratom bottles; and 5-count, 20-count, 25-count, 40-count, 50-count capsule “Maeng Da Red XS” kratom bottles because they have the potential to be contaminated with Salmonella.

FDA Orders Mandatory Recall for KratomProducts Due to Risk of Salmonella. Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall.  Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

April 18
Recently Posted Guidance     Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations    MDIs and DPIs are products that deliver one or more drug substances to the site of action through the inhalation route.  Both types of products are used to treat lung diseases characterized by obstruction of airflow and shortness of breath, including asthma and chronic obstructive pulmonary disease (COPD), as well as respiratory infections and cystic fibrosis.

April 17
Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil found by FDA Lab analysis.  These ingredients render Euphoric as an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.  To date, Epic Products, LLC has not received any reports of adverse events related to this recall.

April 16
Guidance for Industry - Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  This draft  guidance describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.
 
Guidance for Industry - Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs   This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in a drug’s development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic and review of medical literature and relevant statutes and regulations.  
 
Guidance for Industry - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products based on the FDA’s current thinking on this subject.  Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.  
 
Guidance for Industry - E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population   The purpose of the addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

April 13
FDA to Extend Comment Period on Draft Guidance Regarding Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products. The comment period is being extended by 45 days on the draft guidance for industry concerning the declaration of added sugars on honey, maple syrup, and certain cranberry products.  Electronic comments can be submitted at http://www.regulations.gov. Written comments can be submitted to Dockets Management Staff (HFA-305), Food and Drug Administration,  5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-0075, as listed in the notice of availability that publishes in the Federal Register.

April 10
CDER Small Business and Industry Assistance is announcing the Regulatory Education for Industry (REdI) Spring Conference.  May 15-16, 2018  Hyatt Regency San Francisco Airport Burlingame, CA 94010   Conference Webpage  I   Registration  I  Agenda  Attend on-site or virtually online.  Registration for this event is FREE, and is required in advance.  Conference Topics include:  IND Content, Format, Submission, CMC Requirements, and Safety Reporting, Nonclinical Assessment for Small Molecules and Biologic Drug Development;  FDA Regulatory Requirements for Clinical Investigators;  Pre-Approval Manufacturing Site Inspections;  Communication Pathways; and more!

April 4
Nutrizone Expands Recall of Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk.  NutriZone, LLC of Houston, Texas is updating an incorrectly reported lot number provided in an earlier press release.  Previously, NutriZone indicated the Paint Out Maeng Da lot number was 10957.  The correct lot number is 10959.  Consumers who have purchased the products should verify the lot number.

April 2
FDA Investigates Salmonella Typhimurium Outbreak Linked to Dried Coconut.  On April 2, the FDA identified 16 retail locations that were supplied with potentially contaminated bulk dried coconut.  This updated information is in addition to previous information identifying recalled packaged products.  CDC reports a total of 13 people were infected with the outbreak strain of Salmonella Typhimurium, across eight states: California (5), Colorado, Connecticut, Idaho, Missouri, Oregon (2), Texas, and Utah. Three people have been hospitalized, but no deaths have been reported.  As a result of FDA testing, Vitamin Cottage Natural Food Markets has recalled Natural Grocers brand Coconut Smiles Organic and International Harvest has recalled Go Smiles Dried Coconut Raw and International Harvest Brand Organic Go Smile! Dried Coconut Raw.


Specialty Pharma Monthly Newsletter (March 2018) 

Mar 30     FDA warns consumers not to use highly contaminated diaper rash treatment made by Industria Farmacéutica Andrómaco The U.S. Food and Drug Administration is alerting consumers of a voluntary recall of a topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico.  FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected.

Mar 29     FDA approves new treatment for Acute Radiation Syndrome Adding to the Country’s Available Treatments in the Event of Radiological or Nuclear Emergency.  On March 29, 2018, the FDA approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS). Myelosuppression occurs when radiation damages the bone marrow. Suppression of the bone marrow blocks the production of blood cells. Leukine can help patients with H-ARS by facilitating recovery of bone marrow cells that develop into white blood cells that help fight off infections.  Leukine was shown to increase survival when administered up to 48 hours after total body irradiation exposure at doses expected to be fatal to 50% of those exposed subjects under conditions of minimal supportive care.   

Mar 29     The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).  MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse. There is a risk of serious adverse reactions in pediatric patients due to benzyl alcohol preservative; therefore, the drug prepared with preservative free saline should be used for patients weighing less than 22 kilograms. 

Mar 28     Rhino 69 Extreme 50000 and Red Zone Xtreme 3000 both contain a hidden ingredient: tadalafil, the active ingredient in Cialis.  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. 

Mar 28     Black Lion Pill contains a hidden drug ingredient, sildenafil, the active ingredient in Viagra.  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. 

Mar 26     Disposal of Unused Medicines: What You Should Know (updated).  Also click on   https://www.drugs.com/article/drug-expiration-dates.htmlto read JAMA’s “Drug Expiration Dates – Are They Still Safe to Take?”  

Mar 26     Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry . Outsourcing facilities are also subject to FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that help to mitigate the risks of the drug products they compound. Outsourcing facilities may or may not obtain prescriptions for identified individual patients and can, therefore, distribute compounded drugs to healthcare practitioners for “office stock,” to hold in their offices in advance of patient need. 

Mar 26    Guidance for Industry Postmarketing Safety Reporting for Combination Products  This guidance addresses how to comply with the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the "combination product PMSR final rule," "final rule," or "rule"). 

Mar 26     Guidance for Industry Compliance Policy for Combination Product Postmarketing Safety Reporting  This guidance document is intended to assist Combination Product Applicants who are subject to the Combination Product Postmarketing Safety Reporting Final Rule.   FDA does not intend to enforce certain requirements under the rule, specifically 21 CFR 4.102(c) and (d), 4.104(b)(1) and (b)(2), and 4.105(b), for a period of time.  

Mar 23     Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities.  These provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need – the 503B bulks list.  Please visit: Advancing FDA’s oversight of drug compounding.  

Mar 22      CDER SBIA Chronicles:  A New Era of Homeopathic Drug Product Regulation   Issues of this newsletter are archived at: 

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm299560.htm

Mar 21     FDA Warns Salmonella Typhimurium Outbreak Linked to Dried Coconut.  Testing by the FDA has confirmed that Salmonella found in two retail product samples of dried coconut collected from Vitamin Cottage Natural Food Market and International Harvest are a match to the outbreak strain. CDC reports a total of 13 people were infected with the outbreak strain of Salmonella Typhimurium, across 8 states: California (5), Colorado, Connecticut, Idaho, Missouri, Oregon (2), Texas, and Utah. Three people have been hospitalized, but no deaths have been reported.

Mar 20     Animal Studies Indicate Monoxidil May Improve Blood Vessel Structure.  To find out whether an oral The scientists found that minoxidil lowered blood pressure and vessel stiffness to levels similar to healthy mice. Imaging tests showed that vessel diameter and blood flow to the brain increased in the minoxidil-treated mice. One month after the drug was stopped, the diameter was still enlarged, suggesting that the structure of the blood vessel walls had changed. Using protein analyses and tissue studies, the team showed that minoxidil increased elastin deposits in blood vessels. Gene studies revealed that minoxidil revs up not only elastin and elastic fiber genes but also more than 100 other genes related to blood vessel structure form of minoxidil can remodel the vessel’s wall to reduce blood vessel stiffness and enhance blood flow to the brain, researchers studied the drug’s effects in mice.  The research team studied mice that were genetically modified to have low levels of elastin in their blood vessels. As a result, the mice had high blood pressure, increased blood vessel stiffness, and reduced blood flow to the brain. One group of modified mice received minoxidil in their drinking water from weaning until 3 months, a second group was treated for only the two weeks before elastin gene studies, and a third group had plain water instead. The scientists found that minoxidil lowered blood pressure and vessel stiffness to levels similar to healthy mice. Imaging tests showed that vessel diameter and blood flow to the brain increased in the minoxidil-treated mice. One month after the drug was stopped, the diameter was still enlarged, suggesting that the structure of the blood vessel walls had changed. Using protein analyses and tissue studies, the team showed that minoxidil increased elastin deposits in blood vessels. Gene studies revealed that minoxidil revs up not only elastin and elastic fiber genes but also more than 100 other genes related to blood vessel structure.          

 

Mar 20      FDA is Investigating Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom.  These products have been linked to a multistate outbreak of salmonellosis from multiple strains of Salmonella. Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.  These products are marketed in many forms, including leaves, pills, capsules, powder and tea, and may not mention kratom on the labeling. Other names for kratom that have been identified by the U.S. Drug Enforcement Administration (DEA) are: Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang. Read more at:   http://s2027422842.t.en25.com/e/es?s=2027422842&e=56792&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=a9ccbb29010b4795acd51811f2593591&elqaid=2614&elqat=1

Mar 20     The FDA approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.  Adcetris has a boxed warning that highlights the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection that can result in death.  Serious risks of Adcetris include peripheral neuropathy; severe allergic (anaphylaxis) or infusion-site reactions; damage to the blood, lungs and liver (hematologic, pulmonary and hepato-toxicities); serious or opportunistic infections; metabolic abnormalities (tumor lysis syndrome); serious dermatologic reactions and gastrointestinal complications.  

Mar 16     FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus products due to labeling errors.   Bayer is voluntarily recalling Alka-Seltzer Plus® packages that:   1. Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry's Food Stores, Ralphs, King Soopers and Smith's Food and Drug) after February 9, 2018, and 2. Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

The affected packages are being recalled because the ingredients listed on the front sticker of the carton may be different from the ingredients listed on the back of the carton as well as the product in the carton. This may lead consumers to ingest an ingredient to which they are allergic to, or should not be taking, because of the potential for serious health consequences.

 

Mar 14    FDA working to withdraw Zinbryta from the market in the United States.  On March 2, Biogen and Abbvieannounced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile.  Recently, the European Medicines Agency announced a recall of Zinbryta following 12 reports of serious inflammatory brain disorders worldwide. FDA is aware of these reports and is conducting a review of similar events.  Any questions or concerns about the withdrawal can be directed to the manufacturers’ service    

Mar 13     Guidance for Industry:  M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in pharmaceuticals To Limit Potential Carcinogenic Risk  Download your copy by control- click on the title above.

Mar 6       Intermittent dietary restriction may boost physical endurance. Animal studies show that intermittent fasting can improve overall health and prevent certain diseases. Whether the same applies to people is a subject for future study.  When energy intake is restricted for more than 12 to 16 hours, glycogen stores in the liver become depleted. The body then switches from glucose to fats as a source of energy. Extended exercise can cause a similar shift. Fatty acids are metabolized to compounds called ketones. This metabolic state, called ketosis, brings a host of changes throughout the body.  Read more at:   https://www.nih.gov/news-events/nih-research-matters/intermittent-dietary-restriction-may-boost-physical-endurance

Mar 2       Draft Guidance –Definitions of Suspect Product and Illegitimate Product for Verification Obligations under the Drug Supply Chain Security Act   This guidance is intended to help industry identify suspect and illegitimate product in the prescription drug distribution system in the United States by interpreting certain terms used in the definitions of suspect product and illegitimate product. Trading partners are required to take specific actions if they identify such products.  Download your copy at:  https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm598737.pdf

Mar 2       Draft Guidance – Standardization of Data and Documentation Practices for Product Tracing   This guidance is intended to assist trading partners in standardizing the product tracing information that is captured, maintained, and provided to the subsequent purchaser, FDA, or other appropriate State or Federal officials pursuant to the requirements under section 582 of the FD&C Act.  Get your copy at:  https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm598734.pdf

Mar 2       FDA Warns of Fraudulent and Unapproved Flu Products.  This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies.  These flu claims may indicate that an OTC product is fraudulent:

1.  reduces severity and length of the flu;  2. boosts your immunity naturally without a flu shot;  3. safe and effective alternative to the flu vaccine; 3. prevents catching the flu;  4. effective treatment for the flu;  5. faster recovery from the flu; or  6. supports your body's natural immune defenses to fight off the flu.  For more information visit: FDA Warns of Fraudulent and Unapproved Flu Products   

Mar 1       FDA Alerts Health Care Professionals and Patients Not To Use Compounded Drugs from Cantrell Drug Company of Little Rock, Arkansas.  FDA investigators most recently inspected Cantrell’s facility in June 2017, and observed poor compounding drug operations. Of particular concern, the FDA investigators observed insanitary conditions and violations of current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health. Because Cantrell produces drugs that are intended for sterile injection, the conditions identified — which can expose such products to contamination and render them unsterile — raise significant public health concerns. In response to the FDA’s recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding. However, against FDA advice, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified.

Mar 1       FDA is Working to Reduce the Risk of Loperamide (Imodium) Misuse and Abuse.  Recently, FDA began taking steps to implement packaging limitations for the common anti-diarrhea medicine loperamide, which is sold over-the-counter (OTC) under the brand name Imodium, under store brands, and in generic form. The agency is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. 

Mar 1       Suspect Molecules Overlap in Autism, Schizophrenia, and Bipolar Disorder.  Drs. Daniel Geschwind and Michael Gandal of the University of California Los Angeles (UCLA), and colleagues, examined gene expression in postmortem brains of people who had been diagnosed with autism spectrum disorder (ASD), schizophrenia, bipolar disorder, major depressive disorder, or alcoholism.  The study demonstrated – for the first time – that disorders with a large overlap in genetic risk factors also had a large overlap in patterns of gene expression and shared dysfunction in similar molecular pathways. For example, the researchers found that synapse and neuro-immune functions were similarly impacted in autism, schizophrenia, and bipolar disorder.  The study also highlights the importance of such large-scale team science efforts in gaining insights into the biology underlying mental disorders 

 


Specialty Pharma Monthly Newsletter (February 2018)

Feb 27       FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease.   FDA advised caution before prescribing the antibiotic clarithromycin (brand name Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.  Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body.  Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.  To listen to the Drug Safety Podcast on this topic control/click

Feb 27       Blood test detects several cancer types.  Researchers developed a blood test, called CancerSEEK,  that can detect signs of eight types of common solid tumors: breast, colorectal, esophagus, liver, lung, ovary, pancreas, and stomach.  Researchers have been working to develop tests that can detect bits of tumor material in bodily fluids such as blood or urine. These tests, sometimes referred to as liquid biopsies, could potentially be used to catch cancers much earlier, long before symptoms appear.  With further development, the test could allow for earlier detection of several types of cancer.   The scientists estimate that the test will cost less than $500.  Further testing will be needed to measure the accuracy and predictive value of CancerSEEK in a clinical setting.

Feb 23       Bella All Natural issues voluntary nationwide recall of diet capsules labeled as Bella, due to presence of Sibutramine.  Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns.  Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.  The product is used as a diet pill and is packaged in a plastic bottle, with 30 pills, and with the Lot Number MFD:10.15.2017 EXP: 10.14.2019. Bella was distributed in California via internet and retail.

Feb 16       FDA approves new indication for Imfinzi (durvalumab). The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).  Common side effects of Imfinzi in patients with stage III unresectable NSCLC include cough, fatigue, inflammation in the lungs (pneumonitis/radiation pneumonitis), upper respiratory tract infections, difficulty breathing (dyspnea) and rash.

Feb 16 Draft Guidance “Early Alzheimer’s Disease: Developing Drugs for Treatment.  Download HERE.

Feb 16      FDA Poster:  What Makes a Generic the Same as a Brand-Name Drug.  Download your copy.

Feb 16       FDA Poster:  Exclusivity and Generic Drugs: What Does It Mean.  Download your copy HERE.

 Feb 15       Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up.   Fountain Run, KY: Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15 (Carton), NDC# 50268-061-11 (Blister Card), Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.  Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Unintentional dosing of Torsemide, 20mg, Tablets could cause excessive urination.

Feb 14       FDA approves new treatment for prostate cancer using novel clinical trial endpoint.  The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).  This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.  Common side effects of Erleada  include fatigue, high blood pressure (hypertension), rash, diarrhea, nausea, weight loss, joint pain (arthralgia), falls, hot flush, decreased appetite, fractures and swelling in the limbs (peripheral edema).

Feb 14       Invitation to attend public workshop on Generic Drug Regulatory Science Initiatives   The Food and Drug Administration (FDA) is hosting the FY 2018 Generic Drug Research Public Workshop to give an overview of the status of regulatory science initiatives for generic drugs. We want your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information obtained from the public workshop into account in developing our fiscal year 2019 regulatory science initiatives.  The meeting will be held at FDA’s main campus in Silver Spring, Maryland, on May 24, 2018, from 8:30 a.m.–4:30 p.m. and will be webcast for those who cannot attend in person.  f you wish to attend in person or via webcast, please email GDUFARegulatoryScience@fda.hhs.gov  by April 24, 2018. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and whether you will be attending in person or by webcast). Those without email access can register by contacting Stephanie Choi (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4736, Silver Spring, MD 20993, 240-402-7960) by April 24, 2018. If you need special accommodations because of a disability, please contact Stephanie Choi no later than April 24, 2018. 

Feb 13       Generic User Fee Amendments    On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications.  GDUFA was reauthorized on August 18, 2017 (GDUFA II), with provisions that went into effect October 1, 2017 and remain in effect through September 30, 2022.  More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page. 

Feb 13       Injection prompts mouse immune system to destroy tumors.  In studies using mouse models, scientists found a combination of agents that, when injected into a tumor, directs the immune system to destroy not only the injected tumor, but tumors of the same type throughout the body.  This tumor vaccination approach doesn’t depend on knowing the unique characteristics of a tumor, so it could in theory be applied to many forms of cancer.  Read more HERE.

Feb 13      Compound repairs features of Alzheimer’s disease in mice.  Researchers found that a compound called an NAD+ precursor helped mice with features of Alzheimer&rsquo, ;s disease perform better on learning and memory tests.  The findings pave the way for studies of the compound’s potential as an intervention for people with Alzheimer’s disease.  Read more HERE.

Feb 7         Considerations for applicants deciding when to submit elemental impurity data to FDA   Download your copy HERE.

Feb 6         CDER SBIA Chronicles:  "FDA Helping the Generic Industry Submit Complete Applications" February 6, 2018 Issue   Download your copy by control/click on the colored title above.

Feb 1         New FDA Drug Safety Communication on Ocaliva (obeticholic acid)  The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury.   Ocaliva has been shown to improve a certain blood test that measures liver problems in patients with PBC. It works by increasing bile flow from the liver and suppressing bile acid production in the liver, reducing the exposure of the liver to toxic levels of bile acids. Progressive PBC can lead to liver failure or death.  Treatment of PBC with Ocaliva may delay or prevent progression of the disease.  

Jan 30       FDA Drug Topics:  FDA Adverse Events Reporting System (FAERS) Public Dashboard.  On Tuesday, January 30, 2018, CDER's Office of Communication, Division of Drug Information (DDI) hosted this webinar which provided an overview of the FAERS Public Dashboard, a highly interactive web-based tool that allows for the querying of FAERS data in a user-friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers. FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public.  To view the presentation and download presentation slides go to the FDA website HERE.


Specialty Pharma Newsletter (April - July 2016)

July 16      Voluntary nationwide recall of oral liquid docusate sodium manufactured by PharmaTech and distributed by Rugby Laboratories- Drug Information Update.  U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.  FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

July 15      Guidance for Industry:  Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product under Section 503A of the Federal Food Drug and Cosmetic Act.  To obtain your copy download at:   Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

July 15     Guidance for Industry: Compounded Drug Products That Are Copies of Approved Drug Products.       To obtain your copy download at:   Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  

Also the FDA released a this notice announcing the two guidance on Compounding:  FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs

July 15      FDA Approves an Increase to the Amount of Vitamin D for Milk and Milk Alternatives.  The                       approval, which amends existing food additive regulations, will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.  Manufacturers may begin using the new amounts on July 18, 2016.

July 13      FDA Posts Notice Announcing a Change in its Procedure for Inspections of Certain Human Drug                   Compounders Starting August 1, 2016.  Read at notice 

July 12      Drug Information Update - FDA approves new medication for dry eye disease.  The U.S. Food                     and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of  drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.  The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).  Safety and efficacy in pediatric patients below the age of 17 years has not been studied.

July 12      Guidance for Industry:  Updating ANDA Labeling After the Marketing Application for the                   Reference Listed Drug Has Been Withdrawn.  Download your copy by Control /Click on this link:                     “Updating ANDA Labeling after the Marketing Application for the Reference Listed Drug (RLD) Has                        Been Withdrawn.”  

July 12      Paragraph IV Patent Certifications.  The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Division of Filing Review at 240-402-8859, before making any decisions based on this information.

                  Go to Paragraph IV Patent Certifications (PPIV) (PDF - 2.3MB) by Control/Click on the colored statement.    

July 11      Public Notifications:  The Following Products Contain Hidden Drug Ingredients.  Dream Body                   Advanced, Acai Weight Loss & Cleanse, Dream Body Extreme Gold, Dream Body Original Formula, Extra Slim Plus Acai Berry Weight Loss Formula, and SBF Bee Pollen.

July 8        FDA Approves First Retinoid Drug for Over-The-Counter (OTC) Use to Treat Acne - Drug                   Information Update.  The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene),  a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.  Differin Gel 0.1% should not be used on damaged skin (for example, cuts, abrasions, eczema, or sunburn). People using Differin Gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips and mouth.    

July 1        You  Can Search all FDA Official Guidance Documents and Other Regulatory Guidance by Using this Website:  Control/Click on:     Search all FDA official guidance documents and other regulatory guidance

June 30     Guidance for Industry:  Elemental Impurities in Drug Products Guidance for Industry                (PDF - 100KB)  Control/Click on the colored print above to read.

June 30   FDA requests additional information to address data gaps for consumer hand sanitizers.  The FDA today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC).  The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.  The proposed rule will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, and comments on any new data or information may then be submitted to the docket for an additional 60 days. 

June 28     FDA approves Epclusa for treatment of chronic Hepatitis C virus infection.  The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.  Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness. 

June 24     Quality Metrics Technical Conformance Guide: Technical Specifications Document (PDF - 114KB)  To review your copy, Control/Click on the above colored title.

June 24     The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.  A new CDER Conversation has posted. The topic is the generic drug approval process, featuring Ted Sherwood, Director, Office of Regulatory Operations, Office of Generic Drugs, CDER. The U.S. Food and Drug Administration requires a generic drug company produce enough data to demonstrate it can make a drug that can be appropriately substituted for its brand-name counterpart. The challenge for the generic drug maker is to prove to FDA that the generic version is substitutable with a brand-name drug that has been shown to be safe and effective. FDA’s challenge is to carefully review that data to ensure it proves the same thing. This conversation discusses how both do their job. For more information, please visit: The Generic Drug Approval Process by Control/Click on the colored title in this sentence.

June 22     FDA Drug Shortage.  Theophylline Extended Release Tablets and Capsules (Updated - Currently in Shortage)

June 21     Racial disparities in stroke incidence and death.  A stroke occurs when blood vessels that supply the brain become ruptured or blocked. When blood can’t bring nutrients and oxygen to brain cells, the cells stop functioning and die.  Studies have found that black people between the ages of 45 and 54 die of strokes at a rate that’s 3 times greater than their white counterparts. This difference declines with increasing age, so that by the age of 85 it no longer exists.

June 17         Guidance for Industry: Quality Attribute Considerations for Chewable Tablets.  View by Control/Click on this link  Quality Attribute Considerations for Chewable Tablets Guidance for Industry

June 16     FDA seeks input on product-specific recommendations to facilitate generic drug development.  FDA has published 33 product-specific recommendations (18 new and 15 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.  For more information and to view the recommendations, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm 

June 14     Redefining health and well-being in older adults.   Based on the NIH health information topics you requested to receive information about, the FDA thought you'd be interested in this story from NIH Research Matters:  https://www.nih.gov/news-events/nih-research-matters/redefining-health-well-being-older-adults

June 13     New update to the Drug Safety Communication on Zecuity (sumatriptan)- Drug Information Update.  Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. 

June 10     OTC Monograph User Fees Public Meeting Was Held on June 10th.   FDA held a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

June 9       Pharmacy Compounding.  FDA issues final guidances on interim policy for certain bulk drug substances used in compounding.  See at:  http://www.fda.gov/Drugs/DrugSafety/ucm502075.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  (paste in browser)

June 9       FDA Guidance on Pharmacy Compounding.  Read by Control/Click on  Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance

June 9       FDA finalizes interim policy on compounding using bulk drug substances   Today the FDA issued          &nbs, p;     &nbs, p;  two final guidances on compounding using bulk substances:

·               Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the                   Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 127KB)

·               Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the                   Federal Food, Drug, and Cosmetic Act (PDF - 106KB)                                                        The agency also posted a statement and a webpage related to these two guidances: 

·               FDA issues final guidances on interim policy for certain bulk drug substances used in compounding

·               Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding; Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. For more information on pharmacy compounding, go to FDA’s Information on Compounding

 June 9      Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Guidance for Industry.  The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND.   Federal Register Notice      Guidance Document

June 9       FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch.   On June 2, 2016, FDA announced it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.  Patients should not bathe, shower, or swim while wearing the patch. Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the patch immediately. Consider a different formulation of sumatriptan or switch patients to an alternative medicine. Evaluate patients and application site as needed.The Zecuity patch is designed to deliver a dose of medicine by way of a single-use, battery-powered patch wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.  Since marketing began in September 2015, a large number of patients have reported experiencing burns or scars on the skin where the patch was worn. Reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. We are investigating to determine whether future regulatory action is needed.

June 9       FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX-Drug Information Update.  The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.  

June 9      FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin. 

                  On June 6, 2016, FDA warned consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.   OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generics.  Taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.      

June 8       Nature Made® Recalls Various Products Because of Possible Health Risk.  Pharmavite LLC is recalling specific lots of Nature Made® products detailed  below due to possible Salmonella or Staphylococcus aureus contamination.                                                          Nature Made® Adult Gummies Multi          

                        Nature Made® Adult Gummies Multi + Omega-3                                                                                                    Nature Made® Adult Gummies Multi for Her plus Omega-3s

                        Nature Made® Super B Complex w/C & Folic Acid Tablet

June 8       New Drug Safety Communication on Imodium (loperamide) and loperamide products – Drug Information Update.  The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide.

June 7       Can You Lengthen Your Life?  Researchers Explore How To Stay Healthy Longer“If I had to rank behaviors in terms of priority, I’d say that exercise is the most important thing associated with living longer and healthier,” says Dr. Luigi Ferrucci, an NIH geriatrician who oversees research on aging and health. “Exercise is especially important for lengthening active life expectancy, which is life without disease and without physical and mental/thinking disability.”

June 6       FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient deathControl/Click to read 

June 1       FDA approves Zinbryta to treat multiple sclerosis.  The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.  “Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.  Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. 

June 1       FDA approves Ocaliva for rare, chronic liver disease.  On Friday, May 27, the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.  PBC is a chronic, or long lasting, disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed.  “Patients left untreated, or who have not responded to UDCA, are at risk for liver failure and death,”

May 31     FDA approves new diagnostic imaging agent to detect recurrent prostate cancer.  The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.  “Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Axumin is shown to provide another accurate imaging approach for these patients.”

May 26     FDA approves new implant for the treatment of opioid dependence.  The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.  Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed.

May 26     The FDA has finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA).   It will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply.   Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

May 23     Prescription Drug User Fee Act (PDUFA).  The President signed into law the Food and Drug Administration Safety and Innovation Act1 (FDASIA), which includes the reauthorization of PDUFA through September 2017. PDUFA V will provide for the continued timely review of new drug and biologic license applications.

                  The FY 2016 user fee rates have been published (posted 8/3/2015):

                  Application with Clinical                                               $ 2,374,200

                  Application without Clinical                                             1,187,100

                  Supplement with Clinical                                                  1,187,100

                  Product                                                                                114,450

                  Establishment                                                                       585,200

May 19     CDER SBIA Chronicles: FDA Embraces Emerging Technology for Bioequivalence of Locally Acting Nasal Sprays.  Download the FDA/CDER Chronicles at: https://mail.google.com/mail/u/0/?ui=2&ik=c74809db4c&view=pt&search=inbox&msg=154c9d6c4ba9a433&siml=154c9d6c4ba9a433

May 19     Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration’s (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.

May 18     Drug Information Update- New Drug Safety Communication on Canagliflozin.  The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the ris, k of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

May 13      SOS Telecom, Inc. Recalls New Unapproved   Drugs Marked as Dietary Supplements.  SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making this tainted dietary supplement and unapproved drug.  Products affected:  Tiger-X, Ninja-X, Genseng Power-X, Super Samurai-X.  These products were marketed as dietary supplements for male sexual enhancement. 

May 13     FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries.  The FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, , BiCNU (carmustine for injection) 100 mg, has been detected in, some foreign countries. There is no indication at this ti, me that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU.  The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc.

May 12     FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.  The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.  An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

May 12     FDA Issues Final Guidance on Frequently Asked Questions About Medical Foods. m The U.S. Food and Drug Administration has published a resource to give industry more information about the definition and labeling of medical foods.  The final guidance for industry “Frequently Asked Questions About Medical Foods: Second Edition,” represents FDA’s current thinking on medical foods. This second edition, which finalizes the August 2013 draft guidance, provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance.  Medical foods are specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are not those foods simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.  Control/Click on: Final Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

May 10     Statement on FDA’s Actions on Labeling of KIND Products.  In March 2015, the FDA issued a warning letter to KIND LLC, because the labels and labeling of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims.  Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” only in text clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information. In our discussions with KIND, we understood the company’s position as wanting to use “healthy and tasty” as part of its corporate philosophy, as opposed to using “healthy” in the context of a nutrient content claim,  Consumers want to make informed food choices and it is the FDA’s responsibility to help them by ensuring labels provide accurate and reliable nutrition information. In light of evolving nutrition research, forthcoming Nutrition Facts Labeling final rules, and a citizen petition, we believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term “healthy.”

May 6       The Generic Drug User Fee Amendments of 2012 (GDUFA) Fiscal year 2017 self-identification reporting period is open from May 1st to June 1st, 2016. Self-Identification is an annual requirement, whether or not company information has changed.  GDUFA requires that human generic drug facilities and certain sites and organizations identified in a generic drug submission provide identification information annually to FDA.  We also offer the following web-based learning courses to help you understand GDUFA:                                                                                                                                              1.  Overview of the Generic Drug User Fee Amendments of 2012                                                                             

2.  Generic Drug User Fee Amendments Self-Identification Structured Product Labeling (SPL) Submission Part 1 and Part 2   (Use Control/Click on blue/violet statements to view)

May 5      FDA reminds health care professionals not to use drug products intended to be sterile from Medaus.  The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile.  Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.  The majority of these drugs are hormone replacement products, such as injectables and implantable pellets, and injectable nutritional products, such as vitamins, minerals and amino acids.  Medaus’ drug products intended to be sterile were distributed nationwide and were also exported internationally. 

May 4       FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S.  The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other.

May 3       New Drug Safety Communication on aripiprazole.  The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced.   As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

May 3       New Drug Safety Communication on Brintellix (vortioxetine).  The U.S. Food and Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016.

May 3       FDA Approves First Drug to Treat Hallucinations and Delusions Associated with Parkinson’s Disease.  The U.S. Food and Drug Administration approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.  Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.  

Apr 30      , Federal judge enters order of permanent injunction against Paul W. Franck.  The U.S. Food and Drug Administration announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida. According to the complaint filed with the consent decree, Franck manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The U.S. Department of Justice brought the action on behalf of the FDA.  The order prohibits Franck from manufacturing, holding and distributing sterile drug products until he complies with the FD&C Act and its regulations, in addition to other requirements.  

Apr 29      Guidance - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.   Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496288.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                  or control/click on:  Facility Definition Under Section 503B of the, Federal Food, Drug, a, , nd Cosmetic Act

Apr 29      FDA approves first generic Crestor.  The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets.   Generic drugs approved by the FDA have the same quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.  Watson Pharmaceuticals Inc. of Parsippany, New Jersey has received approval to market generic rosuvastatin calcium in multiple strengths.  (Editor's note:  As of June 2016 the price of the generic was about the same as the brand [Crestor].  Typically it takes 6 to 9 months for the generic price to fall to competitive generic levels)

Apr 29      FDA Regulation of Marijuana.    Download slides by control/click on:                                                            FDA Regulation of Marijuana: Past Actions, Future Plans

Apr 28      Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples.

Apr 18      Three New Draft Guidance Related to Compounding of Human Drugs.  These apply to both outsourcing facilities and compounders seeking to operate under section 503A.

                Guidance :  Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 82KB)   Control/Click to view guidance.

                Guidance :  Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 296KB)   Control/Click to view guidance.

                     Draft Guidance: Hospital and Health System Compounding Under the Federal Food, Drug, and       Cosmetic Act    Control/Click to view guidance.

Apr 11      Guidance for Industry:   Contents of a Complete Submission for the Evaluation of Proprietary Names      Control/Click to view guidance.

Apr 8        New Drug Safety Communication on metformin.  The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function.  We have concluded from the review of studies published in the medical literature that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. We are requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.

Mar 25      Draft Guidance:  General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral       Opioid Drug Products.  Control/Click onGeneral Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry    

Mar 24      FDA Warns Consumers Not to Use “Best Bentonite Clay”.  “Best Bentonite Clay,” is a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk.  Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.

Mar 23      New Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines and requires label changes.   The U.S. Food and Drug Administration (FDA) is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels.   Opioids are a class of powerful narcotic pain medicines that are used to treat moderate to severe pain that may not respond well to other pain medicines (see List of Opioids). They can help manage pain when other treatments and medicines are not able to provide enough pain relief, but they also have serious risks including misuse and abuse, addiction, overdose, and death.

                  List of Opioids  alfentanil - Alfenta;   buprenorphine - Belbuca, Bunavail, Buprenex, Butrans, Suboxone, Zubsolv;    butorphanol - No brand name currently marketed;    codeine - Fioricet w/ codeine, Fiorinal w/ codeine, Tylenol w/ codeine;     dihydrocodeine - Synalgos-DC;     fentanyl - Abstral, Actiq, Duragesic, Fentora, Ionsys, Lazanda, Sublimaze, Subsys;    hydrocodone - Anexsia, Hysingla ER, Lortab, Norco, Reprexain, Vicodin, Vicoprofen, Zohydro ER;    hydromorphone - Dilaudid, Dilaudid-HP, Exalgo;    meperidine - Demerol;    methadone - Dolophine, Methadose;    morphine - Astramorph PF, Duramorph PF, Embeda, Infumorph, Kadian, Morphabond, MS Contin;    oxycodone - Oxaydo, Oxycet, Oxycontin, Percocet, Percodan, Roxicet, Roxicodone, Xartemis XR;   oxymorphone - Opana, Opana ER;    pentazocine- Talwin;    remifentanil - Ultiva;    sufentanil - Sufenta;    tapentadol - Nucynta, Nucynta ER;    and    tramadol - Conzip, Ultracet, Ultram, Ultram ER          

Mar 16      FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals.  The U.S. Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used.  The plastic safety seal or tamper-evident ring, also known as a collar, or band, should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. A loose safety seal or ring presents a safety risk as it may cause eye injuries.  Consumers and health care providers who have these products should not attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper.

Specialty Pharma Newsletter (January - March 10, 2016)

Mar 10      Nestlé USA Announces Voluntary Recall of a Limited Number of DiGiorno® Pizzas, Lean Cuisine® and Stouffer’s® Products Due to the Potential Presence of Foreign Material (Glass Pieces).  Consumers who may have purchased the products listed above should not consume them but should instead contact Nestlé Consumer Services at 1-800-681-1676.  A list of products with UPC and Best Before Dates is available at:   http://www.fda.gov/Safety/Recalls/ucm490200.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 10     Drug Information Update:  FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd. Austin, TX due to lack of sterility assurance.   During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.  On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. 

Mar 10     FDA Issues Final Guidance for Industry on How to Reduce Acrylamide in Certain Foods,  The U.S. Food and Drug Administration (FDA) has issued final guidance to the food industry to help growers, manufacturers and food service operators take steps to reduce levels of acrylamide in certain foods.   Acrylamide is a chemical that may form in certain foods during high-temperature cooking, such as frying, roasting and baking. The National Toxicology Program (an interagency program that evaluates possible health risks associated with exposure to certain chemicals) characterizes the substance as “reasonably anticipated to be a human carcinogen.” The focus of this non-binding guidance is on raw materials, processing practices, and ingredients pertaining to potato-based foods (such as french fries and potato chips), cereal-based foods (such as cookies, crackers, breakfast cereals and toasted bread), and coffee, all sources of acrylamide exposure. Additional advice to consumers pertaining to acrylamide, including recommended food storage and preparation methods, is available on FDA.gov.

Mar 9        Today, the U.S. Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate), for the treatment of erectile dysfunction.  Teva Pharmaceutical Industries received approval to market generic sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity.  For information about the availability of these products, contact the manufacturer. 

Mar 9        FDA statement on Menu Labeling Enforcement  As a result of language in the omnibus appropriations bill enacted December 18, 2015 (Public Law 114-113 Consolidated Appropriations Act, 2016), FDA is delaying enforcement from December 1, 2016, to the date that is one year after it issues final, Level 1 guidance on menu labeling. The draft Level 1 guidance was issued on Sept. 11, 2015, and FDA is considering all comments received and will issue the final guidance as soon as possible.

Mar 9        CDER Small Business and Industry Assistance (SBIA) announces the Regulatory Education for Industry (REdI) conference "Generic Drugs Forum 2016" at the Doubletree Hotel in Silver Spring, MD. April 13-14, 2016.  This event is free.  For info and registration paste this link into your browser:  http://sbiaevents.com/?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Mar 9        Warning Letters                                                                                                                                        Raphah, Inc., P.O. Box 7166, North Brunswick, New Jersey 08902                                                     Recent FDA inspection of Raphah's dietary supplement manufacturing facility in New Brunswick, New Jersey revealed a number of significant violations of 21CFR Part 111 cGMP regulations for dietary supplements.  Among the violations: failure to establish specifications for components, for in-process manufacturing steps, for labeling and packaging, and for finished "Bioenergy" products and their labeling.  Failure to follow a written manufacturing record (MMR) for each unique formulation.  Failure to conduct identity testing, and failure to conduct tests and examinations and conducting a material review.                                                                                                                            .

                  Herbal Energetics/In Joy Organics, 32 Bay Hill Road, Northfield, New Hampshire 03276

                  Recent FDA inspection of your facility revealed that your products  “X Out-Rays,” “Stop It Cold,” “SOS Flower Essence,” “Decongest,” “Smoke No More,” “Goodbye Pain,” “Cough Release for Babies and Small Children,” “Cough Release,” “Childrens Stop It…Cold Flu,” “Viral Resolve,” and “Flu the Coop.” are intended for use as unapproved new drugs.

                  VitaSea Products Int’l, Inc. dba Wachters Organic Sea Products, 550 Sylvan St., Daly City, CA 94014

                  We (FDA) evaluated your website at Internet address www.wachters.com and determined that claims on your website establish your products as intended for use as unapproved new drugs.

                  Gordondale Farms, Inc., P.O. Box 26, Nelsonville, Wisconsin 54458-0026

                  We (FDA) found that you offered for sale an animal for slaughter as food that was adulterated.  Our investigation also found that you hold animals under conditions that fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply.   Failure to take prompt action to correct this situation may result in regulatory action without further notice such as seizure and/or injunction.

                  HoneyCombs  Industries, LLC., 10671 6075 Road, Montrose, Colorado 81403

                  An inspection of your dietary supplement manufacturing facility located at 10671 6075 Road, Montrose, Colorado revealed that your products Cough Syrup, Formula C&F (Cold & Flu) Liquid Alcohol Free Extract, Month 6 (Parasites & Microbes), and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract are intended for use in the cure, mitigation, treatment, or prevention of disease and are considered to be unapproved new drugs.

                  Chemolee Lab Corporation, 3820 Conflans Road, Irving, Texas 75061

                  During a recent FDA inspection we identified significant violations of current Good Manufacturing Practices (cGMP) for finished pharmaceuticals.  Among violations we found that the following products are unapproved and/or misbranded drugs in violation of the FD&C Act: (b)(4) Restless Legs Cream, (b)(4) Restless Legs Cream, (b)(4) Shingles Anti-Itch Recovery Cream, (b)(4) Shingles Recovery Cream Anti-Itch Formula, (b)(4) Lung Cream Herbal Formula, (b)(4) Anti-Inflammatory & Pain Relief Cream, (b)(4) Diabetic Foot Cream Anti-Itch Formula, and (b)(4).            

                  Sharim Distributing Co., Inc., 1115 W. Hayward Avenue, Independence, Missouri  64052

                  FDA has determined that certain products you distribute, including but not limited to, “(b)(4) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].  FDA confirmed through laboratory analysis that “(b)(4)” contain the following undeclared phosphodiesterase type-5 (PDE-5) inhibitors: sildenafil  and dithiodesmethylcarbodenafil.  These products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling.

Mar 8        Guidance for Industry: 

                  Environmental Assessment: Q & A Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity.  The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses.  Environmental Assessments must be submitted as part of certain NDAs, abbreviated new drug applications (ANDAs), biologic license applications (BLAs), supplements to such applications, and investigational new drug applications (INDs).   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444658.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                  Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of TransfusionTransmission of Zika Virus.  We, FDA, are providing you, blood establishments that collect Whole Blood and blood components, with recommendations for donor screening, donor deferral and product management to reduce the risk of transfusion-transmitted Zika virus (ZIKV).  Download at: 

 http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM486360.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 26       FDA Posts Questions and Answers on Spice Safety.   For more information Control/Click on the link:                                                                                                  Questions & Answers on Improving the Safety of Spices

Feb 26       CDERLearn.   CDERLearn, the web page for educational tutorials offered by the Center for Drug Evaluation and Research (CDER). CDER's primary mission is to make certain that safe and effective drugs are available to the American people. There is, however, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process, the vital role health care professionals play to assist FDA in fulfilling its duties, and many other important issues.   To learn more paste this address into your browser:  http://www.fda.gov/Training/ForHealthProfessionals/ucm090162.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Feb 23       Senescent cells tied to health and longevity in mice.  Removing senescent cells — those that had stopped dividing — extended the lifespan of mice and had other health benefits without apparent side effects.  The results suggest that therapies aimed at removing senescent cells could help counter some effects of aging.   Taking advantage of the fact that senescent cells express certain unique genes, they designed transgenic mice in which injection of a drug triggers senescent cells' death.   Cellular senescence is a biological mechanism that functions as an ‘emergency brake’ used by damaged cells to stop dividing.   While halting cell division of these cells is important for cancer prevention, it has been theorized that once the ‘emergency brake’ has been pulled, these cells are no longer necessary.

Feb 19       Drug Information Update- FDA approves new drug to treat partial onset seizures.  The U.S. Food and Drug Administration approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.   The most common side effects reported by people taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.   As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. 

Feb 17       Enforcement Report - Class III

                  Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only.    Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540.  Reason:  Failed Impurities/Degradation Specifications; 9 month stability timepoint.

Feb 12       Guidance for Industry

                  (Instructions to download the following three documents: (control + click on the colored link, then right click and "select" the address in the pop up, then press "enter", then click on the download arrow at the right hand corner of your screen to view)

                  Completeness Assessments for Type II API DMFs Under GDUFA .  For a copy, select this link:  Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry

 

                  Allergic Rhinitis: Developing Drug Products for Treatment.  For a copy, select this link:   

                   Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry   

 

                  Nonallergic Rhinitis: Developing Drug Products for Treatment.   For a copy, select this link:   

                   Nonallergic Rhinitis: Developing Drug Products for Treatment

 

Feb 11     Drug Information Update - FDA alerts compounding pharmacies of a nationwide voluntary recall of SyrSpend SF and SyrSpend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast (Candida galli).   If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.

Feb 5         Products that Contain Hidden Ingredients.

                  Genseng Power X, Boss Number Six, Golden Night, Mamba is a Hero, Ninja-X contain hidden ingredients which are sildenafil and sulfoaildenafil; tadalafil; sildenafil, and hydroxythiohomosildenafil; sildenafil, desmethyl carbodenafil, and dapoxetine; sildenafil and thiosildenafil, respectively.

Feb 10       Enforcement Report - Class II

                  Lyrica (pregabalin) capsules, 50 mg & 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017.  Reason:  FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

                  Nystatin, USP Powder for Rx compounding, 150 Million Units and 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427.  Reason:  Labeling: label error on declared strength.

Feb 5         Products that Contain Hidden Ingredients.

                  Genseng Power X, Boss Number Six, Golden Night, Mamba is a Hero, Ninja-X contain hidden ingredients which are sildenafil and sulfoaildenafil; tadalafil; sildenafil, and hydroxythiohomosildenafil; sildenafil, desmethyl carbodenafil, and dapoxetine; sildenafil and thiosildenafil, respectively.     Black Ant, Herb Viagra, Real Skill, Stree Overlord, Weekend Prince, and African Black Ant all contain sildenafil.   Wonder-Erect Male Gum and Wonder Erect Male Pills contain vardenafil (Levitra).

Feb 1         Drug Information Update - FDA is reminding consumers to be wary of so-called “chelation” products that are marketed over-the-counter.  The U.S. Food and Drug Administration (FDA) is reminding consumers to be wary of so-called “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases such as lead poisoning. Companies that make unapproved products often highlight that their product contains the same ingredient as an FDA-approved drug, suggesting that it is OK for them to market their drug without FDA approval.  These products are not FDA approved.  Chelation involves the use of certain chemicals to remove heavy metals from the body.  In medicine, chelation has been used for the treatment of metal poisoning, among other conditions.  FDA has never approved any chelation product for OTC use for any health condition.  All FDA-approved chelation products require a prescription because they can only be used safely under the supervision of a health care practitioner.  Illegal OTC chelation products are frequently marketed to deceive consumers into thinking they are taking a product that has been evaluated by FDA. 

Jan 29       The Food and Drug Administration (FDA) is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning.  FDA laboratory analysis identified mercury in the product.  Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.  Mercury can also interfere with brain development in children. Signs and symptoms of mercury poisoning include, irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around the mouth.  Consumers are encouraged to report unlawful sales of products, including “Crema Piel De Seda,” to FDA through our website at: Reporting Unlawful Sales of Medical Products on the Internet.

Jan 29       Drug Information Update - FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay due to potential lead poisoning risk.  “Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.

Jan 28       FDA seeks input on product-specific recommendations to facilitate generic drug development.  FDA has published 47 product-specific recommendations (35 new and 12 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.  FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of BE guidances.  For more information and to view the recommendations, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm

Jan 28       Drug Information Update - FDA approves first drug to show survival benefit in liposarcoma.  The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.  Soft tissue sarcoma (STS) is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells. STS can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen.

Jan 26       Schedule for Guidance that CDER is Planning to Publish During Calendar Year 2016.  You can download your copy at:   Guidance Agenda: Guidances CDER is Planning to Publish During Calendar Year 2016

                  (control + click on the colored link, then right click and "select" the address in the pop up, then press "enter", then click on the download arrow at the right hand corner of your screen to view)

Jan 21       FDA/CDER SBIA Chronicles -  Best Communications Practices with FDA.   Issues of this newsletter are archived at http://www.fda.gov/cdersmallbusinesschronicles

Jan 20       Enforcement Report

                  DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02.  Reason:  Failed Impurities/Degradation Specifications - High out of specification test result for impurities during stability testing.

Jan 19       FDA Warns Consumers Not to Use Licorice Coughing Liquid.  The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine.  The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine,  consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product.  This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product.

Jan 5         Draft Guidance

                  Unique Device Identification: Convenience Kits.  You can obtain a copy at:

                  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm479242.pdf

                  Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.   You can obtain a copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm478821.pdf

Dec 31       Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph.

                  FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.  To see the Federal Register Notice on this topic 

                  control + click on  Federal Register Notice     or paste this address into your browser:  https://www.federalregister.gov/articles/2015/12/23/2015-32246/fixed-combination-and-co-packaged-drugs-applications-for-approval-and-combinations-of-active?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery

 

Dec 28       Medication Fraud - More Products with Hidden Drug Ingredients.

                  Rhino Big Horn, Rhino 7 Blue 9000, OrgaZen 3500, OrgaZen 3000, Triple Miracle Zen Plus,

                  Triple Miracle Zen Gold, Triple Miracle Zen Extreme, Eros Power Zone 1900, and Diamond 3500.

                  They contain ingredients like desmethyl carbodenafil, sildenafil, tadalafil, dapoxetine, etc.

 

Specialty Pharma Newsletter (April –July 2015) 

Jul 24        FDA Proposes Additional Revisions to the Nutrition Facts Label.  The supplemental proposal would, among other things, require declaration of the percent daily value (%DV) for added sugars. The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families.  The FDA is accepting public comments starting July 27, 2015.  For more information go to:  http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

July 24      Life and More issues recall of Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.

July 22      Enforcement Reports                                                                                                                                          Class III:                                                                                                                                   HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL.   Reason for Recall:  Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable.                                                                          Class II:                                                                                                                                       Nitroglycerin Transdermal System 0.2 mg/hr. (10 cm2) and 0.4 mg/hr. (10cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-0 Reason for Recall:  Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.   

July 22      Warning Letters                                                                                                                                                Vista Pharmaceuticals Ltd., Nalgonda District Andhra Pradesh 508254 India   Dr. Dhananjaya Alli  failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012 (GDUFA).   Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 

Jul 17        Guidance for Industry.  Testicular Toxicity: Evaluation During Drug Development (Draft).  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455102.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Jul 15        Enforcement Reports                                                                                                                             Class I                                                                                                                                                             Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11.  Reason for Recall:  Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.                  

 Jul 15        Class II                                                                                                                                              Losartan potassium tablets USP, 25 mg, 50 mg, and 100 mg, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9    Reason for Recall:  Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.                                                                                    Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.  Reason for Recall:  CGMP Deviations: Firm did not adequately investigate customer complaints.

 

Jul 14        CDER SBIA Chronicles:  “Import-Export” May 2014.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM454794.pdf

Jul 13        FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes.  Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.   Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib 

Jul 13        FDA Drug Shortages:                                                                                                                     Morphine Sulfate (Avinza) Extended Release Capsules have been discontinued.     

Jul 10        FDA Approved Rexulti (brexpiprazole) Tablets to Treat Adults with Schizophrenia and as an Add-on Treatment to an Antidepressant Medication to Treat Adults with Major Depressive Disorder (MDD).   MDD, commonly referred to as depression, is also a severe and disabling brain disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities.  

Jul 8          FDA approves new drug to treat heart failure.  The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.  Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure generally worsens over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

Jul 6          Guidance For Industry                                                                                                                              The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy.  This guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving product tracing information, prior to or at the time of a transaction or do not capture and maintain the product tracing information, as required by the FD&C Act.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm453225.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                   

  

    Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.  This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.  Get your copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377938.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

     Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations.  FDA is seeking public comment on whether the uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated products currently designated essential are no longer essential under the Clean Air Act due to the availability of alternatives that do not use CFCs or because the products are no longer being marketed. Essential-use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act.  Read the Federal Register Notice at:  https://www.federalregister.gov/articles/2015/06/29/2015-15902/use-of-ozone-depleting-substances-request-for-comment-concerning-essential-use-designations?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery  

Jun 22       FDA approves new antiplatelet drug used during heart procedure.  The FDA approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.   According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year.

Jun 19       Guidance for Industry:  Naming of Drug Products Containing Salt Drug Substances.  Read this guidance at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm379753.pdf

Jun 15       FDA alerts health care providers, researchers and patients not to use certain products from ScienceLab.com   FDA investigators inspected the headquarters of ScienceLab.com in Houston, Texas and observed conditions that could result in a lack of sterility of purportedly sterile drug products, which puts patients at risk.  FDA asks health care providers to report to FDA if they have sterile product from ScienceLab.com in inventory by sending an email to: CDERDrugSupplyChainIntegrity@fda.hhs.gov

Jun 11       Guidance for Industry                                                                                                                   Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Product – Content and Format.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450636.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 June 10     Enforcement Reports    Class II                                                                                                                                       Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.   Reason for  Recall:  Failed Dissolution Specifications: Low out of specification dissolution results.

 

                  Zebeta® (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01  Reason for Recall:  Failed Dissolution Specifications: OOS result during stability testing 

                  SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433   Reason for Recall:   Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Hon,, ey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

                  Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02.  Reason for Recall:   cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

                  Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02.  Reason for Recall:   cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure. 

Jun 10       FDA Issues Draft Guidance on Developing Drugs for Duchenne Muscular Distrophy.  Read at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450229.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jun 8         Medication Disposal: Questions and Answers.   Website address: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 29   Guidance for Industry:                                                                                                                                  1.   ANDA Submissions – Refuse-to-Receive Standards.  Download your copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm370352.pdf                                                                                                    2.   Established Conditions Reportable CMC Changes for Approved Drug and Biologic Products (DRAFT).   Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM448638.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 May 28     FDA Drug Shortages:                                                                                                                                    1.   Methylphenidate hydrochloride ER Capsules/Tablets                                                                       2.   Gemifloxacin Meslate (Factive) Tablets                     

May 28     FDA Approves Rapamune to treat lymphangioleiomyoatosis (LAM), a very rare lung disease that attacks women of childbearing age.  LAM is characterized by an abnormal growth of smooth muscle cells that invade lung tissues, including the airways, and blood/lymph vessels that cause destruction of the lung, resulting in airflow obstruction, and limiting the delivery of oxygen to the body. LAM is a very rare disease. According to the U.S. National Library of Medicine, only between two and five women per million women worldwide are known to have the disease.

May 28     FDA approves two therapies to treat IBS-D.  The U.S. Food and Drug Administration approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.  According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

May 22   Guidance for Industry:                                                                                                                                  1. Compounding Animal Drugs from Bulk Drug Substances.  Read at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-av-gen/documents/document/ucm446862.pdf 

May 22     FDA Warns That SGLT2 Inhibitors for Diabetes May Result in a Serious Condition of Too Much Acid in the Blood.  Type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.  SGLT2 inhibitors are not FDA approved for patients with type 1 diabetes, as safety and efficacy have not been established.

May 21     FDA Cautions About Dose Confusion and Medication Errors for Antibacterial Drug Zerbaxa.  FDA is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.  To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Thus, one vial of Zerbaxa will now list the strength as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram.  

May 20     CDER SBIA Chronicles:  “Patents and Exclusivity” May 2014.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM447307.pdf

 May 18     Orange Book (updated)                                                                                                                                     1.  April 2015 Additions and Deletions to the Drug Product List.  Read at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM447006.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                                    2.  Cumulative Supplement 6 June 2015.   Read at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 18     FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Rx Drugs.   For information on safe purchasing practices, see FDA’s Know Your Source Campaign:  http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm  

May 15     Guidance for Industry:                                                                                                                                 1.   Investigational New Drug Applications Prepared and Submitted By Sponsor-Investigators.   Download at:   http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm446695.pdf                                                                                           2.   Biosimilars:  Additional Questions and Answers Regarding Implementation of Biologics Price Competition and Innovation Act of 2009.  Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm273001.pdf

May 15     Inactive Ingredients Database Download.   Go to:  http://www.fda.gov/Drugs/InformationOnDrugs/ucm113978.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                                                           Inactive Ingredient Search for Approved Drug Products.  Go to:  http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 15     FDA Drug Shortages:                                                                                                                                   1.  Chloroquine Phosphate Tablets        

May 14     Guidance for Industry                                                                                                                                    1.  Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.  Get your copy at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm333969.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery  

                  2.  Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (DRAFT).  This document is available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070246.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery      

 May 13     Enforcement Reports  Class I                                                                                                                                 ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. Reason for Recall:  Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein 

                  0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.  Reason for Recall:   Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. 

May 13     Enforcement Reports  Class II                                                                                                                   C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414  Reason for Recall:  Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL   

May 12     The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection.     Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year. The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague and septicemic plague.  Plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. The bacteria that causes plague, Yersinia pestis, is considered a biological threat agent that could potentially be used as a bioterrorism agent. 

May 8       Guidance for Industry:                                                                                                                                 1.  Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs.   Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-av-gen/documents/document/ucm052460.pdf                                                                                    2.  Waver of In Vivo BA and BE Studies for Immediate Release Solid Dosage Forms Based on a Biopharmaceutics Classification System (DRAFT).  Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070246.pdf                                                                                            3.   Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.  Download at:   http://www.fda.gov/ucm/groups/fdagov-public/documents/document/ucm291128.pdf

May 5       Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil® (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL) Due to Particulate Matter.

                  Mylan Initiates Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter:  Gemcitabine, Methotrexate, Carboplatin, and Cytarabine

 Apr 30       Public Notification - The following products contain hidden drug ingredients:                              1. Slim Forte Slimming Capsule                                                                                                                        2. Li Da Dai Dai Hua Slimming Capsule                                                                                                3. King of Romance                                                                                                                                4. Viagra 007                                                                                                                                                 5. Black Panther                                                                                                                                               6. Extreme Diamond 3000                                                                                                                        7. Akttive Capsules                                                                                                                                8. Zero Xtreme Capsules                                                                                                                                9. Pyrola Advanced Joint Formula                                                                                                         10. SmartLipo

Apr 30      FDA approves treatment for fat below the chin  The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat.   Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.

 

 

Apr 28      Drug Information Update - FDA approves first generic Abilify to treat mental illnesses.  Generic Abilify (aripiprazole). is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Apr 27       FDA Issues a Letter for Manufacturers with Recommendations on Fluoride Added to Bottled Water.  he U.S. Food and Drug Administration (FDA) has issued a letter to industry recommending that bottled water manufacturers, distributors and importers limit the amount of fluoride they add to bottled water so that it contains no more than 0.7 milligrams per liter (mg/L).  The PHS recommendation replaces a previous recommendation for fluoride concentrations that ranged from 0.7-1.2 mg/L, and is designed to achieve an optimal fluoride level that provides the best balance of protection from dental caries while limiting the risk of dental fluorosis

Apr 22       Guidance For Industry:                                                                                                                               1.  Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs (DRAFT).  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 17       Enforcement Report – Class I                                                                                                               0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.   Reason for Recall:  Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.      

Apr 15       The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.  Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.

Apr 7         CDER SBIA Pre-R, ecorded Webinar:  Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry                                                                                                         View Webinar Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions           -Listen to Webinar (Audio Only) Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions (MP3 - 44.2MB)                                                                                                                -Download Presentation SlidesRisk Evaluation and Mitigation Strategies: Modifications and Revisions (PDF - 2.22MB)                                                                                                    Download the Guidance:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM441226.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery           

Apr 2         The U.S. Food and Drug Administration has issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.  Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.  Download the guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Apr 2         CDER Key Official List.   Download at:   http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/UCM070722.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 2        Draft Guidance for Industry; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products.  This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (“products”). This draft guidance revises the guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants” published May 19, 2009.   Read Federal Register Notice at:   https://www.federalregister.gov/articles/2015/03/11/2015-05523/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-applicants-of-prescription?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery  

 

 

Specialty Pharma Newsletter (January – March 2015)

 

Mar 31      Draft Guidance – Development and Submission of Near Infrared Analytical Procedures.  You can download this document at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM440247.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 30      The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a newContraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration. 

Mar 25     Recalls – Class II                                                                                                                                                 Comfort Gel Maximum Strength Antacid & Anti-Gas (Aluminum hydroxide 400 mg, Magnesium hydroxide 400 mg, Simethicone 40 mg in each 5 mL, 1 teaspoon) liquid, 12 FL OZ (355 mL) bottle. Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, Recalled by Tarmac Products, Inc., Reason:  Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.                                                                                                                                                                           

Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle. Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015.  Recalled by Tarmac Products, Inc.  Reason:  Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

Mar 25     The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept)    injection to treat diabetic retinopathy in patients with diabetic macular edema.  Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years.

Mar 25     Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century.   The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic.  Date:  April 20-21, 2015, Time: 9:00 am to 4:00 pm.  Location: FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503A (Great Room) Silver Spring, Maryland 20993.  Contact Information:  CDERhomeopathicproduct@fda.hhs.gov

Mar 23     NIH Research Matters: Physical Activity May Reduce Age-Related Movement Problems.  Age-related brain lesions known as white matter hyperintensities have been linked to movement problems and disabilities later in life. These lesions, which appear as bright spots on MRI images, can be used as a proxy measure of brain white matter disease. They are thought to reflect small blood vessel disease, and have also have been associated with dementia and other health issues in older people.  Read more at:  http://www.nih.gov/researchmatters/march2015/03232015movement.htm

 

Mar 23  New Guidance Document Search Feature.  A new feature on the FDA.gov website allows you to search for guidance documents for all topics across the site from one convenient location:   http://www.fda.gov/RegulatoryInformation/Guidances/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 23      Guidance for Industry: Electronic Submission of Lot Distribution Reports (LDRs)  Under 21 CFR 600.81 applicants must submit to CBER or CDER, as appropriate, LDRs containing certain specified information every 6 months about the quantity of product distributed under their approved biologic license application (BLA) [including to distributors].  Download at:  http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM412006.pdf 

Mar 20      FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic.  OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C"). Read more at:  http://www.fda.gov/Drugs/DrugSafety/ucm438976.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Mar 19     CDER Small Business Chronicles:  Drug Master Files 101.  The topic of this month’s issue of the FDA/CDER Small Business Chronicles is titled “DMF 101” and serves as an introduction to the Drug Master File (DMF). It is possible for a firm submitting an application to FDA to incorporate confidential information submitted by another firm.  This is done via a DMF. The DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs are generally created to allow a party other than the DMF holder to reference material without disclosing to that party the contents of the file.  Get your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM438678.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 18     Public Notification: Ultimate Boost, Xcel and Xcel Advanced contain hidden drug ingredients.   Ultimate Boost and Xcel Advanced contain phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  Xcel contains fluoxetine. Fluoxetine is an FDA- approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD).  Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.  In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.                                     This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.  

Mar 18      The U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease, steatorrhea (presence of fat in the stool) and complications from decreased fat-soluble vitamin absorption.  Individuals with these rare disorders lack the enzymes needed to synthesize cholic acid, a primary bile acid normally produced in the liver from cholesterol. The absence of cholic acid in these patients leads to reduced bile flow, accumulation of potentially toxic bile acid intermediates in the liver (cholestasis), and malabsorption of fats and fat-soluble vitamins in the diet. If untreated, patients fail to grow and can develop life-threatening liver injury. 

Mar 10     Ultra ZX LABS, L.L.C. Issues Voluntary Nationwide Recall of Ultra ZX Since It Contains Undeclared Sibutramine and Phenolphthalein.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.   Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.

Mar 10      Guidance for Industry – Formal Meetings between the FDA and Sponsors or Applicants of PDUFA (Prescription Drug User Fee Act) Products.  Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM437431.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 10     The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.   Neuroblastoma is a rare cancer that forms from immature nerve cells. Unituxin is an antibody that binds to the surface of neuroblastoma cells. Unituxin is being approved for use as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for patients who achieved at least a partial response to prior first-line multiagent, multimodality therapy.

Mar  9      The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with Chantix have been reported. We have approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately. 

Mar  9       FDA approves first biosimilar product Zarxio.  FDA approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.  Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.   Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen.

Mar  9       Draft Guidance for Industry: Clinical Trial Imaging Endpoint Process Standards.  This guidance assists sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that FDA regards as important when imaging is used to assess a trial's primary endpoint or a component of that endpoint. This draft guidance revises the draft guidance entitled “Standards for Clinical Trial Imaging Endpoints” issued on August 19, 2011.  Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM268555.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar  9       Draft Guidance for Industry:  Clinical Investigators, and Institutional Review Boards: Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers.  This guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.  Download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar  6       The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.  Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems.  Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and intravenous formulations.

Mar  6         Public Notification:  Bigger Longer More Time More Sperms (sic), Black Ant King, African Superman, Black Mamba Premium, Black Mamba Hyperrush and L-Carnitine Sob Strengthening Version Slimming Miracle Capsule all contain hidden drug ingredients.  Bigger Longer More Time More Sperms (sic), Black Ant King, African Superman and Happy Passengers  contain Viagra (sildenafil).                              Black Mamba Hyperrush, and L-Carnitine Sob Strengthening Version Slimming Miracle Capsule contain sibutramine. 

Mar  4      The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.  Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.

Mar 4        Drug Information Update - FDA launches drug shortages mobile app.  Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.  The app identifies current drug shortages, resolved shortages and discontinuations of drug products.  The app is available for free download via iTunes (for Apple devices) and Google Play store (for Android devices) by searching “FDA Drug Shortages.”

Mar 4        FDA is hosting the Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2016 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2016 Regulatory Science Plan.  The meeting will be held at FDA’s main campus in Silver Spring, MD, on June 5, 2015, from 9:00am-5:00pmand will be webcast for those who cannot attend in person.

Mar 4        Public Notification: The following products contain the undeclared ingredient sildenafil:   Sex Men, Super Hard, Santi Scalper, Plant Vigra, MME Maxman, and Eliminating Weight & Toxin Keeping Beauty, Night Man, Tibet Babao, 72HP, Vigra, Vigour 300, Hard Wang, FX 3000, Germany Niubian, and Black King Kong

Mar 4        Public Notification: Seven Slim and Nine Slim both contain an undeclared ingredient -phenolphthalein

Mar 4        Public Notification: Botanical Slimming (Red) contains Fluoxetine  which is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD).   Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.

Mar 4        Public Notification: Lean Body contains sibutramine, desmethyl sibutramine, phenolphthalein and sildenafil.

Mar 2        Guidance Agenda: New and Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2015.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 2        FDA is Announcing the 2015 REdl: Generic Drugs Forum.  This will take our previous GDUFA and You conference to a new level by expanding our content to other regulatory aspects that concern the generic drug industry.  April 22-23, 2015, The Sheraton Silver Spring Hotel, Silver Spring, MD.  This two-day conference offers you the opportunity to interact with FDA subject matter experts as we discuss various topics along the dynamic continuum of the generic drug approval process. This forum will be delivered in a hybrid format (you can attend virtually or in person).  Topics include:  Current Regulatory Practice in Type II API DMF Review, Update on Question-based Review (QbR), and Proper Regulatory Submission During the Lifecycle of Generic Drug Products.  This event is FREE, but you must register at:  http://sbiaevents.com/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 26      Drug Information Update - FDA approves new antibacterial drug Avycaz.  The U.S. Food and Drug Administration, on February 25, 2015, approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

Feb 19       Pharmacy Compounding Guidance

1.      Draft Guidance for Industry - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities. Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434188.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

2.      Draft Guidance for Industry - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  This draft guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434171.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3.      Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the States and the Food and Drug Administration; New Proposed Draft.  FDA is announcing the availability for public comment of a draft standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the State of [insert State] and the U.S. Food and Drug Administration.” The draft standard MOU describes the responsibilities of the State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products.  Obtain more information at:  https://www.federalregister.gov/articles/2015/02/19/2015-03420/memorandum-of-understanding-addressing-certain-distributions-of-compounded-human-drug-products?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery

4.      Draft Guidance for Industry - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. This guidance describes the conditions under which FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility repackages human drug products.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434174.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Feb 19       Draft Guidance for Industry - Alcoholism: Developing Drugs for Treatment.  The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism.  Download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm433618.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 19     Guidance for Industry - Complicated Urinary Tract Infections: Developing Drugs for Treatment.  The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). This guidance finalizes the revised draft guidance of the same name issued on February 24, 2012. Get your copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070981.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 17       Drug Information Update - FDA approves Lenvima for a type of thyroid cancer.  The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).  The most common type of thyroid cancer, DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

Feb 9         Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements Due to the Presence of Undeclared Drug Ingredients.  Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs. FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. 

Feb 9        FDA issues revised Draft Guidance for Industry on Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.  Download your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM069984.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Feb 6         Guidance:  Individual Patient Expanded Access Applications Form FDA 3926.   Expanded access requests are sometimes referred to as compassionate use 22 requests. Individual patient expanded access allows for the use of an investigational drug outside 23 of a clinical investigation for an individual patient who has a serious or immediately life­ 24 threatening disease or condition and there is no comparable or satisfactory alternative therapy to 25 diagnose, monitor, or treat the disease or condition.  Get your copy at:   http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm432717.pdf

Feb 4         Drug Information Update- FDA approves Ibrance for postmenopausal women with advanced    breast cancerBreast cancer in women is the second most common type of cancer in the United States. It forms in the breast tissue and in advanced cases, spreads to surrounding normal tissue. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.  Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells.

February Warning Letters

                  Cadila Pharmaceuticals Limited, Gujarat, India   CGMP violations causing their Active   Pharmaceutical Ingredients (APIs) to be adulterated.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421544.htm

                  Novacyl (Thailand) Ltd., Samutprakam Thailand.  CGMP violations causing their APIs to be adulterated.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436268.htm  

                  Infiniti Creations, Inc., Lindon, UT 84042   Products marketed in violation of the FD&C Act.     Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436079.htm

                  Modern Herb Shop, Inc.  Sacramento, CA 95667  Products promoted for conditions that cause them to be new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436074.htm

                  Nutreglo Products, Inc. Miramar, FL 33029   Products promoted for conditions that cause them to be        new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435680.htm

                  Twin Falls Bio Tech, LLC, Hilton Head Island, SC 29926 Products promoted for conditions that cause them to be new drugs.  Download at:   Products promoted for conditions that cause them to be        new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htm

                  MyNicNaxs, Inc., Deltona, FL 32725.  Products containing unapproved and undeclared drugs.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436724.htm

                  Better Health Lab, Inc., Hackensack, NJ 07601.     Marketing unapproved new drugs and adulterated and misbranded dietary supplements.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435044.htm

                  StriVectin Operating Company, New York, NY 10001.       Products promoted for conditions that cause them to be new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436692.htm

                  A2Z Industries, LLC, Sherman Oaks, CA 91423.   Marketing unapproved new drugs and adulterated and misbranded dietary supplements.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433809.htm  

                  LCW, Inc., dba uFresh Center and LDF Leaders Maker, San Gabriel, CA 91776  Marketing unapproved new drugs.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435065.htm

Jan 30       Drug Information Update- FDA’s investigation into patients being injected with simulated IV fluids continues.  FDA first became of aware of adverse events at two clinics associated with the mistaken administration of Wallcur’s simulated Practi-0.9% sodium chloride IV in late December and issued a warning to all health care providers not to inject these simulated products in humans or animals on December 30, 2014.  Since then FDA and CDC took a number of steps to remove the simulated saline products from medical settings, raise awareness among health care providers, and provide information to state and local health officials in order to prevent exposure to additional patients.

Jan 30      Drug Information Update - FDA expands uses of Vyvanse to treat binge-eating disorder.  The drug is the first FDA-approved medication to treat this condition.  In binge-eating disorder, patients have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control

Jan 29      Updated Form 2252 along with newly created instructions.  Updates include new expiration date and Field 9b (distribution data)  Download the form at:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083558.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                    Download the instructions at:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM431287.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 28       Draft Guidance for Industry: Evaluating Drug Effects on the Ability To Operate a Motor Vehicle.  The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle.   Get your copy at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm430374.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Jan 28         Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products.  This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products.  Available at:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf 

Jan 28       Proposed Rule: Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products.  FDA is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.

Jan 26       The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD).  Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion.  Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules. 

Jan 22   CDER Small Business Chronicles:  Drugs in Pregnancy and Lactation - Improved Risk Benefit Information.  Included is a discussion of the Pregnancy and Lactation Labeling Rule (PLLR) which sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.  Download your copy today at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM431132.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 14       Recalls – Class II                                                                                                                                                    Gabapentin Capsules, USP, 400 mg, 300 mg, and 100 mg Rx Only, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Tamlinadu, India.   Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.   Reason:  Failed Capsule/Tablet Specifications: Actavis has received several complaints for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

                  HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977 Reason:  Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets (38,788 bottles) due to the presence of small aluminum particles.

Jan 14       Recalls – Class III

                  Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).  Recalling Firm Akorn, Inc. Lake Forest IL.   Reason:  Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

                  Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, and b) one pint (473 mL) bottles, Rx only.   Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.   Reason:  Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Jan 8         Drug Information Update- FDA approves anti-clotting drug Savaysa.  The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.  Savaysa also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days.  DVT is a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. A potentially deadly condition called PE results when a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow.  

Jan 7         Recalls – Class II

                  GINSENG KIANPI PIL, 60 capsules, Product of Kweilin Drug Manufactory.  Recalling Firm: One and Zen, Albuquerque, NM.  Reason:  Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

                  Entertainer's Secret Throat Relief, 2.0 FL oz. (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN.  Recalling Firm: Tropichem Research Labs, Inc. Jupiter, Florida.  Reason:  Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli.

Jan 2         Warning Letters

                  Apotex, Inc. Toronto, ON, Canada M9L 1 T9.   Significant violations of current Good Manufacturing Practice (cGMP) regulations (laboratory records, unauthorized changes to manufacturing records, lack of procedures to prevent microbiological contamination, and QC Unit failure to review and approve drug product control records).

                  Micro Labs Limited, Bangalore 560 001 India.  Significant violations of current Good Manufacturing Practice (cGMP) regulations

                  Aloe Man, Inc. Atlanta, GA 30311.  Unapproved new drugs adulterated and misbranded dietary supplements.

                  Complete H2O Minerals, West Columbia, SC 29169.  Unapproved drugs, misbranded drugs, adulterated and misbranded dietary supplements.

 Dec 31     Draft Guidance – DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.   Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm426126.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 31    Guidance for Industry – DSCSA Implementation:  Product Tracing Requirements – Compliance Policy.  Get your copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm427867.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery.                                                                                                                                                            Note: on December 24 the FDA posted this guidance to inform industry that they do not intend to take action against manufacturers, wholesale distributors, or repackagers who do not, prior to May 1, 2015, provide or capture the product tracing information required by sections 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This action is to minimize possible disruptions in the distribution of prescription drugs in the United States.   For more information, please visit the FDA  “Are you ready for the Drug Supply Chain Security Act” web page, which contains an industry-focused checklist, links and descriptions for each of the DSCSA requirements which go in to effect on Jan. 1, 2015. 

Dec 31      Recalls – Class I

                  MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font.                                                                                                                                                                                             SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font.                                                                                                                                                                ESESMERALDA, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font.   Distributed by: New Life nutritional, New York, NY, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.   Reason:  Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling Super Fat Burner, Maxi Gold Weight Loss Pill and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.

Dec 24    Recalls – Class II

                  Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21  Reason:  Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

                  Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA.  Reason:  Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Dec 23      Drug Information Update - FDA approves weight-management drug Saxenda.  This drug Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.  The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).

Dec 23      Warning Letters

                  Nutri Spec, Inc., Miffintown, PA   Dietary Supplement Violations at both their Miffintown and Indiana facilities as well as Misbranded Dietary Supplements.   Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm428827.htm,

Dec 22      Drug Information Update - FDA approves Opdivo for advanced melanoma.  Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. 

Dec 22      Drug Information Update - FDA approves Rapivab to treat flu infection.  Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days. 

Dec 22       Drug Information Update - FDA approves new antibacterial drug Zerbaxa.  The U.S. Food and Drug Administration approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cU, , , TI).  Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI.  Zerbaxa is the fourth new antibacterial drug approved by the FDA this year. The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.

Dec 22      Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of SLIM-K Capsules Due to Undeclared Drug Ingredients.  Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of SLIM-K collected and tested by the FDA was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.  withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.

Dec 22      Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of B-Lipo Capsules Due to the Presence of an Undeclared Drug Ingredient.  Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain Lorcaserin, a controlled substance used for weight loss.

Dec 19      Drug Information Update- FDA approves Viekira Pak to treat hepatitis C.  The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.  Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Dec 19      Warning Letters

                  Novacyl Wuxi Pharmaceutical Co., Ltd, Wuxi Jiangsu 212185, China.  CGMP violations causing their APIs to be adulterated, as well as significant cGMP violations during manufacture of finished pharmaceuticals.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm427976.htm  

Dec 19      Drug Information Update- FDA approves Lynparza to treat advanced ovarian cancer.  The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.   Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.

Dec 17       Drug Information Update- FDA approves Xtoro to treat swimmer’s ear.  Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.

Dec 17      Recalls – Class III

                  Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx only, 100 Capsules.   Manufacturer: Sandoz Inc., Princeton, NJ 08540 NDC 0781-2822-01.  Reason:  Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

 

Specialty Pharma Newsletter (November-December 2014) 

Dec 17    Tristar Equine Issues Voluntary Recall of Gastrotec.   Gastrotec marketed by Tristar as an OTC drug for use in horses contains a combination of omeprazole and misoprostol. This recall has been initiated due to information from the FDA that Gastrotec must have an approved new animal drug application to be legally marketed in the United States. Gastrotec is not approved by the FDA. As a consequence, Tristar has ceased all production and sales of Gastrotec and is recalling the product.

Dec 17   Guidance for Industry (To be published December 18) Providing Regulatory Submissions in Electronic Format--Standardized Study Data.  You can download your unpublished copy at: CLICK TO DOWNLOAD 

Providing Regulatory Submissions in Electronic Format--Submissions under the Federal Food, Drug, and Cosmetic Act.  You can download your unpublished copy at:    CLICK TO DOWNLOAD 

Dec 17    CDER SBIA Webinar:  Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.  

CDER SBIA is making available its accompanying pre-recorded webinar which: - provides an overview of the reporting requirements for wholesale distributors and third-party    logistics providers under DSCSA

     - describes who must report to FDA,

     - what information should be submitted to FDA,

     - the timing of the submissions,

     - a preferred format for the submissions, and

     - a preferred method for reporting to FDA.

You can download the webinar, presentation slides, and the Federal Registrar notice at: DOWNLOAD

Dec 16    Drug Shortage – Methylphenidate Hydrochloride ER Capsules and Tablets.  This product’s therapeutic categories are pediatric and psychiatry.

Dec 12    Drug Information Update- FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer.   The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).   The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. The National Cancer Institute estimates that 224,210 Americans will be diagnosed and 159,260 will die from lung cancer in 2014.   Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.

Dec 11    Slide Presentation at FDA/CMS Summit: CDER New Drug Review 2014 Update.   View at:  CLICK TO VIEW

Although the new molecular entity program is “running smoothly”, the FDA is still having issues with recruitment and retention of staff.

Dec 10    Recalls – Drugs Class III

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only.   Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc.   Reason:  Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. 

Dec 10    Mental Health Drug Ziprasidone (Geodon) Associated With Rare But Potentially Fatal Skin Reactions.  Ziprasidone is an antipsychotic drug used to treat the serious mental health disorders schizophrenia and bipolar I disorder.   Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS (Drug Reaction with Eosinophilia and Systemic Symptomsis) suspected.   DRESS can lead to death.

Dec 10    Guidance for Industry

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.
Download at:  CLICK TO DOWNLOAD 

Draft - DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third Party Logistics Providers.  CDER Small Business and Industry Assistance will produce a webinar covering this guidance and annual reporting requirements on December 16, 2014. The webinar will be available via the CDER SBIA web page (view webpage)   

Download your copy of the Draft Guidance at:CLICK TO DOWNLOAD

Draft – General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.  
Download at: CLICK TO DOWNLOAD

Dec 10    Warning Letters – Starkist (For what it is worth: Nancy Pelosi’s husband Paul is purported to be a major stockholder in Starkist).  You can download a copy of the warning letter at:   CLICK TO DOWNLOAD

Dec 5      New USP Salt Policy   United States Pharmacopeia’s Monograph Naming Policy for Labeling of Salt Drug Substances in Drug Products and Compounded Preparations is discussed in this video.  Watch at:  CLICK TO WATCH

Dec 4      Guidance for Industry

Draft -  How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategy (REMS) for Reference Listed Drug (RLD).  This guidance is part of FDA’s efforts to assist in certain circumstances where brand-name drug companies refuse to sell to prospective ANDA sponsors supplies of reference listed drugs.
Download at:  CLICK TO DOWNLOAD                 

Draft - Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format.  You can read the Federal Register Notice at: CLICK TO READ

Dec 4      Drug Information Update - FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia.  Precursor B-cell ALL is a rapidly growing type of cancer in which the bone marrow makes too many B-cell lymphoblasts, an immature type of white blood cell. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone marrow cells of leukemia patients. The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.   Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. 

Dec 2      Recalls – Drugs Class II   

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only.  Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 for Actavis Laboratories.   Reason:  Failed Tablet/Capsule Specifications: Presence of split or broken tablets.       

 

Dec 1      Guidance for Industry

Draft Guidance: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.
Download at:  CLICK TO DOWNLOAD

The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.
Download at: 
CLICK TO DOWNLOAD 

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.  
Download at:  CLICK TO DOWNLOAD

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act. 
Download at:  CLICK TO DOWNLOAD

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (DRAFT).  
Download at: CLICK TO DOWNLOAD

Nov 21   Public Notifications - Products Containing Hidden Drug Ingredient

                   Super Extreme Accelerator for weight loss.   Hidden ingredient: Sibutramine

                   Bee Thin for weight loss.  Hidden ingredient:  Sibutramine

                   Black Storm for sexual enhancement.   Hidden ingredient:  Sildenafil

                   Be Slim for weight loss.   Hidden ingredient:  Sibutramine   

                   Feng Shi Ling for arthritic pain with rheumatoid arthritis & osteoporosis. 

                                Hidden ingredients: Diclofenac &  Indomethacin.

                    Forever Beautiful Bee Pollen   No specific indication.  Hidden ingredients:  Sibutramine & Phenolphthalein  

Nov 21   FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties.   The U.S. Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.  The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.  Hysingla ER is not approved for, and should not be used for, as-needed pain relief.

Nov 19   Recalls – Drugs Class III

Simvastatin Tablets, USP, 10 mg, 90 count bottles, Rx Only.    Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90.  Reason:  Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. 

Nov 19   Recalls – Drugs Class II

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle.   Repackaged by Contract Packaging Resources, Inc. 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc., Chesapeake, VA 23320.   Reason:  Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into boxes of Assured Naproxen Sodium Tablets, USP

FLUOCINONIDE GEL USP, 0.05%, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, Rx only.  E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g).  Reason:  Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>. 

Nov 19   Guidance for Industry

Vaginal Microbicides:  Development for the Prevention of HIV Infection.   Download your copy at:  CLICK TO DOWNLOAD 

Rare Pediatric Disease Priority Review Vouchers, DRAFT.  Download your copy at:  CLICK TO DOWNLOAD

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.  Download your copy at:  CLICK TO DOWNLOAD

Nov 19   Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD.    If you are interested in obtaining input on the impact of chagas disease on daily life and patients’ views on currently available therapies to treat the condition.    For meeting information go to:   CLICK FOR MEETING INFORMATION           

 

 

Nov 19    FDA Requesting Comment on Proposed Criteria for “First Generic” Submissions.  FDA is opening a public docket and requesting comments on proposed criteria for “first generic” abbreviated new drug application (ANDA) submissions.  Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made pursuant to GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of “first generic” submissions.  FDA believes that these proposed criteria appropriately focus FDA’s resources on approving new safe and effective generic drug products for patient use as quickly as possible.  For more information and the latest events regarding GDUFA, please visit the Generic Drug User Fee Amendments of 2012 website.   Go to:  CLICK TO GO TO WEBSITE

Nov 18   FDA/CDER Small Business Chronicles November 18 Issue Discusses the “Purple Book”.  You can read it at:  CLICK TO READ 

Nov 18   Orange Book

Additions and Deletions.
Download at:  CLICK TO DOWNLOAD

Cumulative Supplement November 2014.
Download at:  CLICK TO DOWNLOAD

Nov 13   FDA Has Concerns About the Therapeutic Equivalence of two Generic Versions of Concerta Tablets (methylphenidate hydrochloride extended-release).   An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.  In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.  Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.  You can read the current guidance on this subject at:  CLICK TO READ 

Nov 12   Recalls – Class III

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only.   Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.   Reason:  Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

 

Candesartan Cilexetil Tablets, 4 mg, 8 mg, 16 mg, and 32 mg, 30-count bottles, Rx Only.   Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, INDIA, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3.  Reason:  Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

  

Specialty Pharma Newsletter (October-November 2014)

Nov 10   Guidance for Industry - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration  Download your copy at:  CLICK TO DOWNLOAD  

Nov 6     Recalls – Class I

All products, Rx Only  Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613.  Reason:  Lack of assurance of sterility. 

Nov 6     Recalls – Class II

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Weight 16 fl. oz. (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Weight 16 fl. oz. (473 mL), NDC 10702-052-16, Rx Only.   Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.  Reason:  Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.   

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.    Compounded by:   Martin Avenue Pharmacy, 1247 Rickert Drive, Naperville, IL.   Reason:  Lack of assurance of Sterility. 

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc., Parsippany, NJ 07054 USA   Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4.    Reason:  Subpotent Drug 

Nov 4     Public Notification: V26 Slimming Coffee Contains Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use V26 Slimming Coffee, a product promoted and sold for weight loss on various websites and possibly in some retail stores.  FDA laboratory analysis confirmed that V26 Slimming Coffee contains sibutramine.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Nov 5     Warning Letters

Issued to Hikma Pharmaceuticals, Ltd., Ammam, Jordan

Reason: cGMP violations in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.   Specifically, There is a lack of investigations of unexplained discrepancies, and a failure to establish adequate written procedures for production and process control.

Issued to Vitamins Direct (USA), Inc & Golden Pride, Inc. 2540 Metrocentre Blvd, Suite 5 West Palm Beach, FL 33407    

Reason:  Your website promotes products for conditions that cause the products to be drugs under section 201(g) (1) (B) of the Federal Food, Drug, and Cosmetic Act.

Issued to Health Research Laboratories, LLC/New World Health, 433 E Las Colinas Blvd., Suite 1290, Irving, TX 75039   

Reason:  Your website promotes products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.

Oct 31    The Food and Drug Administration is advising consumers not to purchase or use “Ginseng Kianpi Pil,” a product promoted to stimulate appetite, promote weight gain and relieve fatigue, because it contains an undeclared corticosteroid and an antihistamine.  “Ginseng Kianpi Pil” is manufactured by Kweilin Drug Manufactory, and sold in retail stores and on various websites.  FDA laboratory analysis found that “Ginseng Kianpi Pil” contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.

Oct 30    Drug Quality Sampling and Testing Programs.    Every year, FDA monitors and tests hundreds of drug products and active pharmaceutical ingredients to help ensure safe, effective and high-quality products are available to consumers.  FDA has posted details of our postmarket drug quality sampling and testing programs to provide product safety and effectiveness test results to health care professionals and consumers.  To learn more about FDA’s efforts to help ensure the regulatory standards for brand name and generic drugs continue to be met throughout a product’s lifecycle, visit the following webpage;   CLICK TO VISIT WEBPAGE

Oct 30    Request for Comments   FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in draft guidance for industry and review staff.   To learn more go to:  CLICK TO LEARN MORE  

Oct 30    Guidance for Industry - Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.  The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Download at:  CLICK TO DOWNLOAD

Oct 30    Draft Guidance for Industry – Migraine: Developing Drugs for Acute Treatment.   The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine.  Download a copy at:  CLICK TO DOWNLOAD 

Oct 29    Recalls – Class II

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only.   Packaged by Aidarex Pharmaceuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India   Reason:  Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg.

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM, CHERRY AND GRAPE FLAVORS,, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL).  Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, Reason : OTC  Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.  

Numerous lotions, ointments & an expectorant OTC products  Manufactured by NEW GPC INC., A1 Farm, EBD Country of Origin: Guyana.  Reason:  Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements & labeled Not Approved for sale in USA.

MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters    Packaged and distributed by: American Health Packaging, Columbus, OH - Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11.  Reason:  Subpotent; 6 month stability time point. 

ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC     Manufactured for ZEE Medical Inc., Irvine, CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528  Reason:  Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label. 

Oct 29    Drug Discontinuation – Namenda (Memantine Hydrochloride)  The sale of Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA 21-487 indicated for the treatment of moderate to severe dementia of the Alzheimer's type will be discontinued Fall of 2014. The product discontinuation is not related to product safety or efficacy. 

 

Oct 28    CDER List of Guidance Documents    Download your copy at:  CLICK TO DOWNLOAD

Oct 28    CDER Guidance New/Revised/Withdrawn    A copy can be found at:   CLICK TO VIEW COPY

Oct 27    The U.S. Food and Drug Administration on Oct 23, 2014 approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).  Unlike inherited hemophilia, acquired hemophilia A is not a genetic disorder and affects both males and females. The development of acquired hemophilia A has been related to other medical conditions or health states, such as pregnancy, cancer, or the use of certain medications. However, in about half of the cases, no underlying cause can be found. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging.  Obizur contains a recombinant analogue of porcine (pig) FVIII. Porcine FVIII is used because it is similar enough to human FVIII to be effective in blood clotting, but is less likely to be affected by the antibodies against human FVIII that are present in people with acquired hemophilia A.

Oct 27    Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes.  Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria.

Oct 23    Contract Packaging Resources, Inc. Issues a Voluntary Nationwide Recall of Assured™ Brand Naproxen Sodium Tablets due to Packaging Mix-Up.  Greensboro, N.C., Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured™ brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The Ibuprofen bottles were placed in the Naproxen Sodium boxes due to a packaging error. The affected products are: boxes of Assured™ brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.

Oct 22    Recalls – Class III

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles  Manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada  Reason:  Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset.       

Vasotec (enalapril maleate) tablets, RX only.   Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada     Reason:  Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. 

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. and Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S., and Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S, Clonidine HCL, 97 Kg, Rx Only, S.I.M.S.  Chemical Products for Medicines Preparation - Made in Italy.   Reason:  cGMP Deviations: GYMA laboratories of America, Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. 

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only     Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220.  Reason:  Subpotent Drug; for the active, HCB, and preservatives, propylparaben and butylparaben at the 18 month stability test point. 

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only.  

Manufactured by Cadila Healthcare Ltd., Ahmedabad, India  

Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534     Reason:  Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. 

Oct 17  Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit.  Hospira has initiated an investigation to determine the root cause & corrective & preventive actions.   

Oct 17    FDA approves labeling with abuse-deterrent properties for Embeda, an extended-release opioid analgesic.   FDA approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Abuse-Deterrent Opioids – Evaluation and Labeling”.  The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral and intranasal abuse when the product is crushed.

Oct 17    The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).  Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.  The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product’s prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.

Oct 16    Draft Guidance for Industry: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.   FDA has announced the availability of a draft guidance for industry titled: “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.”  FDA is issuing this guidance to assist stakeholders in understanding the effects of section 585 (Uniform National Policy) of the Food Drug and Cosmetic Act, which was added by the Drug Supply Chain Security Act (DSCSA).  The DSCSA establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain. It also requires FDA to establish federal standards for licensing of wholesale drug distributors and third party logistics providers.  Download the Draft Guidance at:  CLICK TO DOWNLOAD 

Find more information on DSCSA at:  CLICK FOR MORE INFORMATION

Oct 16   Draft Guidance for Industry: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.   This draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.   Get your copy at:  CLICK TO DOWNLOAD COPY

Oct 16    Draft Guidance for Industry:  New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.  This draft guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). If the guidance is finalized, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of “new chemical entity,” regardless of whether that drug substance is approved alone or in certain fixed-combinations.
Download at:  CLICK TO DOWNLOAD

Oct 15    Recalls - Class II

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only    Manufactured by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505.   Reason:   Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol. 

Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only   Manufactured for Mylan Institutional, LLC, Rockford, IL 61103.   Reason:  Temperature Abuse: One shipment was inadvertently stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Oct 10    The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.  Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.   Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

Oct 7      FDA is announcing the fee rate of $2,562,000 for using a rare pediatric disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees  for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the rare pediatric disease priority review fee rate for FY 2015 and outlines the payment procedures for such fees. 

Oct 7      Recalls – Class I

BLACK ANT, 2800 mg, four capsules per box, and MOJO RISEN, 650 mg, 2 capsules per pouch, and AFRICAN BLACK ANT, 2800 mg, 6 capsules per box.  Recalling Firm:  Eugene Oregon, Inc.  Reason: Marketed Without an Approved NDA/ANDA Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Oct 7      Guidance for Industry - Pathological Complete Response in Neoadjuvant (i.e. Preoperative) Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval   This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.  
Download at:  CLICK TO DOWNLOAD

Oct 3      The U.S. Food and Drug Administration (FDA) has Published the Fiscal Year 2015 Regulatory Science Priorities for Generic Drugs. 

  • Post-market evaluation of generic drugs
  • Equivalence of complex products
  • Equivalence of locally-acting products
  • Therapeutic equivalence evaluation and standards
  • Computational and analytical tools

Oct 1      Recalls – Class III

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only    Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326.   Reason:  Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.   

Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr.), 1 patch per pouch, packaged in 30-count patches per box, Rx Only.  Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.   Reason:  Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.        

Oct 1      CDER Has Announced Another Web-based Course in its Small Business and Industry Education Series entitled, “Engaging With the FDA During New Drug Development”.  It is designed to help small pharmaceutical business communicate and interact with FDA.   Go to:  CLICK TO VIEW COURSE

Sep 30    Report on the Standardization of Risk Evaluation and Mitigation Strategies.  FDA is announcing the availability of a draft report entitled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as i, t relates to PDUFA.  Go here to read , the report:  CLICK TO READ REPORT 

Sep 24    Recalls – Class I

AFRICAN BLACK ANT, 2800 mg, 6 capsules per box and Black Ant, 4600 mg, four capsules per box, and XZEN GOLD, 750 mg, six capsules per bottle, and XZEN PLATINUM, 750 mg, 1 capsule per blister pack, and Xzone 1200, 750 mg, one capsule per blister pack, and XZONE GOLD, 750 mg, one capsule blister pack, and MOJO RISEN, 670 mg, 2 capsule per pouch. Produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City   Reason: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. 

Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only   Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110.  Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.  Reason:  Failed Content Uniformity Specifications.

Sep 22    FDA approves Trulicity to treat Type Two Diabetes.  The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type two diabetes.  Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type two diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control.  Trulicity has a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies 

Sep 18    The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type two diabetes.  Type two diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type two diabetes received Trulicity. Patients receiving Trulicity, had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).  Trulicity has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Trulicity should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for patients who cannot be managed with diet and exercise. 

Sep 18    The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.  Opioids are a class of drugs that are used to treat and manage pain.  A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.  Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.  Results of the first trial showed that 44 percent of participants receiving 25 mg of Movantik and 41 percent of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29 percent of participants receiving placebo. The second trial showed similar results.  Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

Sep 17    Recalls – Class III  CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml),OTC.  Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.   Reason:  Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

Sept 16   Guidance for Industry:

1)      ANDA Submissions – Refuse to Receive Standards.  This guidance assists applicants preparing to submit abbreviated new drug applications (ANDAs), and related submissions (i.e., prior approval supplements (PASs) for new strengths).  The guidance highlights serious deficiencies in the application ANDA or new strength PAS that may cause FDA to refuse-to-receive the submission.  Download here:  CLICK TO DOWNLOAD

2)      ANDA Submissions - Refuse to Receive for Lack of Proper Justification of Impurity Limits.

This guidance assists applicants preparing to submit to FDA ANDAs and prior approval supplements (PASs) to ANDAs, for which the applicant is seeking approval of a new strength of the drug product.  It highlights deficiencies in information about impurities that may cause FDA to refuse-to-receive an ANDA or new strength PAS. Download here:  CLICK TO DOWNLOAD

Specialty Pharma Newsletter -May-September 2014 

Sept 11   FDA approves weight-management drug Contrave.  The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.  The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Sept 11   Small Business Chronicles: Registration and Drug Listing    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Who, What, When, and How of Registration and Drug Listing.  Obtain your copy at:   Registration and Drug Listing. 

Sept 12   Recalls – Class II

Paroxetine HCL Controlled-Release Tablets 10 mg, 12.5 mg, 20 mg, 25 mg, 37.5 mg, and 40 mg, 30-count bottles and Paxil Oral Suspension, Rx only.   Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328.   Reason:  Chemical Contamination: Products were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. 

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21.  Reason:  Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. 

Sept 10   FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas.  The FDA has issued a formal request to Downing Labs (dba NuVision Pharmacy in Dallas) for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs’ Dallas facility. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of purportedly sterile drug products made at the Downing Labs facility.  Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death. 

Sept 10  FDA publishes Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.  The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).  The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).

Sept 9     CDER SBIA Webinar on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files” – September 16, 2014.  This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.   To register for this Event, please go the following link:  CLICK HERE TO REGISTER  Registration password needs to be 8 characters and alphanumeric. 

Sept 8     Guidance Webinar Invitation: "Uncomplicated Gonorrhea: Developing Drugs for Treatment".  On Thursday, September 11, 2014, from 10:00 a.m. – 11:00 a.m. EDT, FDA will present a webinar on this draft guidance for industry.  The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea.  To access this webinar, click on the following access link:  CLICK TO ACCESS WEBINAR.   The full announcement of the Webinar is found here:   CLICK TO VIEW ANNOUNCEMENT   

Sept 5     Warning Letters

Issued to MicroTest, 104 Gold St, Agawam, MA 01001.  Reason: failure to pay the appropriate facility fee as required by GDUFA. Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded or processed at such a facility are misbranded. Your facility has been placed on a publicly available GDUFA facility arrears list for failure to pay required fees in 2013 and 2014.  

Sept 5     Guidance for Industry:  Electronic Submission of Lot Distribution Reports (PDF-62KB).  You can download this guidance at:   Electronic Submission of Lot Distribution Reports (PDF - 62KB)

Sept 4      Drug Information Update- FDA approves Keytruda for advanced melanoma.  The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.  Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. 

Sept 3     Recalls – Class III 

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only.  Manufactured by Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.  Reason:  Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. 

Aug 26   FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.   This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development.  This guidance also describes FDA’s process for providing communications related to such correspondence. A pre-recorded webinar explaining this draft guidance is available at :  CLICK TO VIEW WEBINAR   You can download this draft guidance at:    Controlled Correspondence Related to Generic Drug Development 

Aug 26   FDA’s new Web-based Learning Course “Human Drug Establishment Registration and Drug Listing Compliance” is available at:  CLICK TO VIEW   

Aug 20   Recalls – Class I

Super ARTHGOLD 500mg, 120 Capsule Bottles, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.  Reason:  Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. 

Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption.  30 pills /Bottle, Distributed by: Bacai, Inc.   Reason:  Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only.   Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer, Inc., New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23.  Reason:  Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 

Aug 20  Drug Information Update - FDA approves new drug to treat a form of Gaucher disease.  The U.S. Food & Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.  Type 1 Gaucher disease is estimated to affect about 6,000 people in the US. 

Aug 19   FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop.    It will be held on October 21, 2014, 8:00 AM to 5:00 PM at the Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814.  There is no registration fee for the public workshop, but for planning purposes, please register at the following site:  https://www.surveymonkey.com/s/BreastWorkshop2014  

Aug 19   Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format.  This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products.
You can download at:Guidance Document 

Aug 19   FDA Announces GDUFA Public Hearing on Policy Development.  It will be held September 17, 2014 from 9:00 AM to 5:00 PM at the College Park Marriott. 3501 University Blvd., East Hyattsville, MD 20783.   Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.  FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics.  Learn more at:  CLICK TO LEARN MORE

Aug 15   Drug Information Update - Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs.   Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.  Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. 

Aug 15   Drug Information Update - FDA warns consumers about fraudulent Ebola treatment products.   The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.  There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. 

Aug 15   Drug Information Update - FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer.  The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.  Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.   Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Aug 15   FDA Small Business & Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014. This event is free. It will be held on September 18-19 at the Hyatt Regency Bethesda in Bethesda, MD. The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation & Research (CDER) & Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant & helpful information on the key aspects of drug & device regulations. Our primary audience is that of small manufacturers of drug &/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. To register go to:     https://www.signup4.net/public/ap.aspx?EID=FDAS18E&OID=130   

Aug 14   Guidance for Industry - Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products – Considerations, Content, and Format.    You can download this guidance at: CLICK TO DOWNLOAD

Aug 14   Drug Information Update - FDA approves Belsomra (suvorexant) to treat insomnia.  The U.S. Food and Drug Administration on August 13, 2014 approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.  Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.  The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. 

Aug 13   Recalls – Class III

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only.  Manufactured by: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10.   Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates. 

Aug 13   Recalls – Class II

All injectables sold by Medical Supply Liquidators, LLC., Clive, Iowa. Reason: Marketed without an Approved NDA/ANDA; IM & SQ injectable products are being recalled because the mnfg firm is not registered with the FDA as a drug manufacturer.

Numerous Durmamedics and Therametrics Skin Creams and Systems.   Distributed by Dermamedics, LLC. Oklahoma City, OK.   Reason:  Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Aug 7   Drug Information Update - FDA approves Orbactiv to treat skin infections.  The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.  Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.

Aug 6     Guidance for Industry – Upper Facial Lines: Developing Botulinum Toxin Drug Products.   You can download this guidance at:   CLICK TO DOWNLOAD 

Aug 5    Guidance for Industry – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.  You can download this guidance at:  CLICK TO DOWNLOAD

Aug 1     Drug Information Update- FDA approves Jardiance to treat type 2 diabetes.    The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. 

Aug 1     FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates.   Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA).   For FY 2015, the generic drug fee rates are: ANDA ($58,730), PAS ($29,370), DMF ($26,720), domestic API facility ($41,926), foreign API facility ($56,926), domestic FDF facility ($247,717), and foreign FDF facility ($262,717). These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.   You can review the Federal Register Notice at:  the fiscal year 2015 generic drug user fee rates 

Jul 30 Recalls – Class I and II

Shamrock Medical Solutions Group LLC, Lewis Center, Ohio, has initiated recalls on its products due to labeling mix-ups where the product labeling is not correct for the product in the package.  Product labeling included in these recalls are:  Diltiazem HCl Capsules, Oxycodone HCL Oral Concentrate, Metformin ER Tablets, Pramipexole Dihydrochloride Tablets, Sulfamethoxazole and Trimethoprim Tablets, and Docusate Calcium Softgel Capsules.         

Franck’s Lab,Inc, dba Trinity Care Solutions, Ocala, FL has initiated a recall of 30 of its products because there is a lack of assurance of sterility. All lots of sterile products compounded by the pharmacy within exp are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Jul 30     Recalls – Class III  

Orphenadrine Citrate Extended Release Tablets, 100 mg a) 100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only.   Manufactured by Sandoz Inc., Princeton, NJ 08540.    Reason:  Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. 

Jul 29    FDA Listing of Authorized Generics as of Jul 29, 2014. Download list at: FDA Listing of Authorized Generic Drugs 

Jul 29    The Sixth Annual Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration’s Office of Medical Policy and the Duke University School of Medicine, is now open for registration.  This extensive 3-day course starting November 4, focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists, and other health care professionals involved in clinical trials- cost $150.   For information and how to register:  http://continuingeducation.dcri.duke.edu/CITC?source=govdelivery&utm_medium=email&utm_source=govdelivery   

Jul 28     Guidance for Industry – (Draft) Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.
Download at:   CLICK TO DOWNLOAD

Jul 25     FDA has published notices in the Federal Register announcing the availability of two draft guidance for industry:

1)    Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under   GDUFA

2)     Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA

Control/Click to follow the above links. 

Jul 25     Recalls – Class III

Teva Pharmaceuticals USA is recalling the following products due to failed impurities/degradation specifications:                Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only,                Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, sold by Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 

Jul 24     FDA approves new extended-release oxycodone with abuse-deterrent properties. The U.S. Food & Drug Administration approved Targiniq ER (oxycodone hydrochloride & naloxone hydrochloride extended-release tablets) an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment & for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death. 

Jul 23    FDA approved Zydelig (idelalisib) for three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned or relapsed. Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. 

Jul 21     Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging.  American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016.

Jul 18     Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs  The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.     According to the indictment, as of July 2004, FedEx employees had identified over 200 accounts that were associated with online pharmacies. By September of 2010, the list had increased to over 600 online pharmacy accounts.

Jul 16    Voluntary Nationwide Recall of Tattoo Ink, Tattoo Needles, Tattoo kits due to Microbial contamination.  White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups distributed by White & Blue Lion.

July 11    Guidance for Industry – Draft - Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act    You can download a copy at:  CLICK TO DOWNLOAD

Jul 11    Dumb and Dumber - Charles Products Recalls Decorative Pint And Shot Glasses Due To Possible Health Risk.  Charles Products, Inc. (CPI) announced today that it is voluntarily recalling shot and pint glasses identified below sold exclusively through M&M’S World retail stores in New York, Las Vegas, Orlando and London.  The company became aware that the glassware may exceed the Food and Drug Administration’s (“FDA”) guidance levels for leachable lead and cadmium. Both lead and cadmium are heavy metals found in the environment that accumulate in human bodies. Both can cause serious health complications at high levels. These glasses should therefore be returned and should not be used for the consumption of beverages, alcoholic or otherwise. 

Jul 8      The Following Products have been cited by the FDA because they contain a Hidden Drug Ingredient (sibutramine or sildenafil): 

1)      Trim Fast Slimming Softgel

2)      Sliming (sic) Diet by Pretty White

3)      Lipo 8 Burin Slim Capsules

4)      24 Ince

5)      Lingzhi Cleansed Slim Tea

6)      Mix Fruit Slimming

7)      Gold Viagra

8)      Miraculous Evil Root

9)      Sport Burner

10)    Toxin Discharged Tea

11)    Burn 7 Capsules (also contain phenolphthalein)

12)    Gold Reallas (contains Thiosildenafil)

13)    Full Throttle On Demand (contains propoxyphenyl sildenafil)

These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 

Jul 8       Draft Guidance for Industry – Best Practices in Developing Proprietary Names for Drugs   You can download this guidance at:  Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs

Jul 8       Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period   FDA is reopening the comment period for the notice of public hearing, published in the Federal Register of February 24, 2014 (79 FR 10168), requesting comment on how to improve or alter the current Over-the-Counter (OTC) Monograph Process for reviewing nonprescription drugs marketed under the OTC Drug Review. FDA is reopening the comment period to update comments and to receive any new information.

Jul 3       FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma   The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.  PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous.

Jun 27   FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots   On June 19, 2014, FDA announced it is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to the labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure that this risk is described consistently in the labeling of all approved testosterone products.  Go to this website to listen:  CLICK TO VIEW WEBSITE   

Jun 27    FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning    Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.  In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.  Recommended alternatives: Use a teething ring chilled in the refrigerator (not frozen), or gently rub or massage the child’s gums with your finger to relieve the symptoms. 

Jun 26       FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products   The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.  They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Based on the information reported to FDA, we cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.  The hypersensitivity reactions may occur within minutes to a day or longer after product use.   Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue; hives or itching. 

Jun 25    FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment  with intravenous chemotherapy drug, docetaxel, contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. 

Several forms of docetaxel are currently marketed including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection. The various products contain different amounts of alcohol, which health care professionals should be aware of in order to monitor and counsel patients appropriately. 

Jun 24    Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product & Notification.  The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, repackagers, wholesale distributors & dispensers) identify suspect products & must begin notifying FDA if it suspects it has illegitimate product in its possession on Jan 15, 2015. This guidance also provides information for supply chain stakeholders about how to notify FDA when they determine that they have an illegitimate product, and how to terminate that notification, consulting with FDA, should it no longer be necessary.  You can download this guidance at:     Guidance for Industry - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification 

Jun 13    Guidance for Industry: Q4B Annex 6: Uniformity of Dosage Units General Chapter   You can get your copy at:   Q4B Annex 6: Uniformity of Dosage Units General Chapter (PDF - 53KB) 

Jun 12    Guidance for Industry: ANDA Submissions--Content and Format of Abbreviated New Drug Applications 
Download at:    ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 215KB) 

Jun 9      Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices    You can receive a copy at:  CLICK TO VIEW COPY

Jun 4      Recalls – Class II

Cefpodoxime  Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Mnfd in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Reason:Presence of Particulate Matter: Presence of stainless steel particles.

May 30  The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.  Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

May 29  Blog: FDA’s Final Guidance on Expedited Drug Approvals.  Read at:  http://blogs.fda.gov/fdavoice/index.php/2014/05/fdas-final-guidance-on-expedited-drug-approvals-fueling-innovation-and-helping-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery   

May 29  Guidance for Industry – Expedited Programs for Serious Conditions-Drugs & Biologics  
Download at:  Expedited Programs for Serious Conditions – Drugs and Biologics (PDF - 276KB) 

May 29 Guidance for Industry – Product Development Under the Animal Rule  
Download at:  Product Development Under the Animal Rule (PDF - 2MB) 

May 29  “JumpStarting” Drug Review    The JumpStart service is modernizing the drug review process—medical reviewers are using this service to quickly and thoroughly assess data from drug clinical trials, ensuring safe and effective products are approved for public use.  Read at:  CLICK TO READ 

May 23  The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.  Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

May 19  NIH:  Longevity Gene Linked to Better Brain Skills.  Read more at:  CLICK TO READ

May 19  2014 GDUFA and You Conference Slides Now Posted   The slides for the “GDUFA and You 2014 Conference” are now posted on our website at:  2014 GDUFA and You Conference Presentation Slides1

May 15  FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose   The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.  As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. 

May 15  FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin   FDA announced that in its ongoing review of the blood thinner Pradaxa (generic name dabigatran), FDA recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin (Coumadin, Jantoven and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction, and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation.    Patients should not stop taking Pradaxa (or warfarin) without first talking to their health care professional. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death.  

May 15  Small Business Chronicles: Drug Shortages – Make an Impact    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Drug Shortages – Make an Impact  Obtain your copy at:     Drug Shortages 

May 14  Guidance for Industry:  ANDAs – Stability Testing of Drug Substances and Products Q&A  Download your copy at:   guidance document  

May 14   Guidance for Industry:  Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product   Download your copy at:   CLICK TO DOWNLOAD

May 5    Guidance for Industry: CMC Post-Approval Manufacturing Changes To Be Documented in Annual Reports 
Download at:  Guidance Document 

Apr 30    FDA approves Zykadia for late-stage lung cancer  The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).  Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizo, tinib, the only other approved ALK tyrosine kinase inhibitor.

Apr 24   FDA approves Sylvant for rare Castleman’s disease  The U.S. Food & Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).  MCD causes an abnormal overgrowth of immune cells in lymph nodes & related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss & weakness or fatigue because their body’s immune system is weakened & cannot fight infections.  Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

Apr 17 &nbs, p; FDA approves Ragwitek for short ragweed pollen  The U.S. Food & Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.  Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ra, ,, g, , , weed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. 

Apr 17  Guidance for Industry – Comprehensive List of Guidance Documents
Download at:  Comprehensive List of Guidance Documents (PDF - 846KB)

Apr 17   Guidance for Industry – Center for Drug Evaluation and Research List of Guidance Documents New/Revised/Withdrawn Jan 1 – June 30, 2014 
Download at:  New/Revised Withdrawn List for 2014 (PDF - 66KB)

 

Specialty Pharma Newsletter - January-April 2014 

Apr 16   FDA Webinar:  Draft Guidance for Industry - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.   On Wednesday, AOn Wednesday, April 23, 2014, from 1:00 p.m. – 2:00 p.m. EDT, FDA will present a webinar on the draft guidance for industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers. Webinar access linkhttps://collaboration.fda.gov/gfiwebinar 

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties emailJeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

To download the guidance, go to:  CLICK TO DOWNLOAD

 Apr 16   Warning Letters

Issued to Driven Sports, Inc., 672 Dogwood Avenue, Suite 329, Franklin Square, NY 11010.  Reason:  Their product CRAZE which is labeled as a dietary supplement, contains a new dietary ingredient which makes it adulterated under section 402(f) of the Act [21 U.S.C. 342b (a) (2) and 21CFR 190.6.

 Issued to Aloe Man International Corp., 18800 NW 2nd Avenue, Suite 102, Miami, FL.  Reason: Their products Gap Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator are products promoted for conditions that cause them to be drugs within the meaning of  section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].  The therapeutic claims on your labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 

Issued to Deseo Rebajar Inc., P.O. Box 7218, Humacao, PR 00792.  Reason:  Your products, "Adipotrim XT," "Burn 7," "Reductrol Fat Burner Formula," ''Adipocleanse," "Adipocleanse XT," "Lipozene," and "Slim Patch" are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)] 

Apr 15   Drug Information Update – FDA Approves Tanzeum to Treat Type 2 Diabetes  The U.S. Food & Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control along with diet & exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety & effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Apr 11   FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  In Aug 2012 FDA added the warning “use of Revatio, particularly chronic use, is not recommended in children” to Revatio’s drug label. A FDA Drug Safety Communication was also issued.  This recommendation was based on clinical trial results showing a higher mortality risk in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.

Apr 11   The products “Infinity” and “Lite Fit USA” Contain a Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use Infinity or Lite Fit USA, products promoted and sold for weight loss on various websites, and in some retail stores.  FDA laboratory analysis confirmed that Infinity contains sibutramineSibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

Apr 10   Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act.  This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.
Download at:  CLICK TO DOWNLOAD

Apr 9     Guidance for Industry:  Immunogenicity-Related Considerations for Approval of Low Molecular Weight Heparin for NDAs and ANDAs.  
You can download at:  CLICK TO DOWNLOAD

Apr 9     Recalls – Drugs Class III

Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only.   Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13.  Reason:  Cross Contamination with Other Products: Product contains Promecta (eltrombopag).

Recalls – Drugs Class II

Duloxetine Delayed-Release Capsules, USP, 20 mg, 30 mg, and 60 mg, Rx Only, 60 capsules per Bottle.   Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06.  Reason:   Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

HydrOXYzine HCl Tablets, USP 25 mg and 50 mg, 100 Tablet Blister, Rx only.   Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01.  Reason:  Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Apr 7     The U.S. Food & Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss & body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the USt. All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the following undeclared drug ingredients:  Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.   Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

Apr 3     Public Workshop:  Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.  FDA will hold the public workshop May 8-9, 2014, at FDA’s White Oak campus in Silver Spring, MD.  You must register by April 24, 2014.  Registration is free. Seats are limited. For more information and registration instructions, please visit:  http://www.fda.gov/Drugs/NewsEvents/ucm388993.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Send questions to: DrugTrackandTrace@fda.hhs.gov        

Apr 2    Public Notification: New You Contains Hidden Drug Ingredients: Sibutramine and Phenolphthalein.  Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”   

Mar 31   Drug Information Update - FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with pulmonary arterial hypertension. 

Mar 31   FDA warns consumers not to purchase or use weight loss product Alli.  The U.S. Food and Drug Administration is alerting consumers that GlaxoSmithKline (GSK) is withdrawing all lots of its weight loss product Alli from the U.S. market because some packages were tampered with and may contain other kinds of pills. 

Mar 31 Five New Guidance Documents

1. Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.  FDA’s recommended practice when discussing unapproved new uses for approved drugs marketed in the US. 
Download at:  CLICK TO DOWNLOAD

2. Drug Development to Treat the Symptoms of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

This guidance will assist sponsors in development of drugs for treatment of VFS/ME. 
Download at:  CLICK TO DOWNLOAD  

3. Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.  This guidance gives the FDA’s requirements pertaining to allowable excess volume in injectable vials. 
Download at:  CLICK TO DOWNLOAD

4. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations.  This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations”.   Download Federal Register Notice at:   CLICK TO DOWNLOAD 

5. Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.   The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. 
Download at:  CLICK TO DOWNLOAD

Mar 31  Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical IngredientsNova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level due to undeclared sildenafil and tadaiafil.

Mar 27  All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing.   FDA and industry have taken action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. 

Mar 26   Pure Edge Nutrition, LLC Issues Voluntary Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.

Mar 26   New Life Nutritional Center Issues Voluntary Nationwide Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. 

Mar 26  Warning Letters – Issued to Mr. Eaga Purushotham, Smruthi Organics Ltd., Solapur, 413 001 India citing the following:

1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards.

2. Failure to maintain and make available for inspectional review production and control records for currently marketed APIs.

3. Inadequate investigations of critical deviations or a failure of a batch to meet its specifications or quality standards.

Mar 25   FDA approves Otezla to treat psoriatic arthritis.  The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).  PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

Mar 24   Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.  You can view the slides from this presentation at:  VIEW PRESENTATION

Mar 21   CDER SBIA Chronicles: GDUFA – Where Are We Now?  The topic of this month’s issue of the FDA/ CDER Small Business Chronicles: GDUFA – Where Are We Now?  You can download your copy at:  CLICK TO DOWNLOAD

Mar 19   Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient.  This product was promoted and sold for weight loss and sold on various websites and in some retail stores.  FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons.

Mar 17   Recalls – Class III 

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only. Manufactured for: Qualitest Pharmaceuticals, Huntsville,  AL NDC 51079-819-20.  Manufactured by: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Rockford, IL.   Reason:  Failed Impurity/degradation Specification.

Mar 17   Recalls – Class II 

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only, C IV. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50.  Reason: Failed Tablet/Capsule Specifications:   Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Mar 17   SNI National is Voluntarily recalling Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 pack Due to Undeclared Drug Ingredients.  These products contain Kratom (Mitragyna Speciosa).  Kratom is a botanical that qualifies as a dietary ingredient under section 201(f) (1) of the Federal Food, Drug, and Cosmetic Act. When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.

Mar 13   CDER Export Certificate Program Frequently Asked Questions. 
Download at:  CLICK TO DOWNLOAD

Mar 13   Pain Free by Nature is Voluntarily Recalling Reumofan Plus Tablets Due to Undeclared Drug Ingredients.  Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries (specific injuries were not detailed in the article).

Mar 12   Recalls – Class II

Cyano B-12 (Cmpd) 1000mcg/ml, Dexamethasone (pf) 0.05 % opth., Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic, Dexamethasone phosphate 24mg/ml inj., Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg, Testosterone Cypionate 200mg/ml, Triamcinolone Acetonide 3mg/ml, Vancomycin (fortified) 25mg/ml opth, Vit A (olive oil) 0.1% opth., Vitamin D (Ergocalciferol) 800 u/ml, and Voriconazole 1% opthal.  Manufactured by Natures Pharmacy & Compounding Center, Ashville, NC.  Reason:  Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Mar 12   The FDA Website “Abbreviated New Drug Application (ANDA) Forms and Submission Requirements” has been updated.  View at: CLICK TO VIEW

Mar 12   The FDA Website, “Generic Drugs: Information for Industry” has been updated.  View at:  CLICK TO VIEW  

Mar 7    The FDA Website, “Opioid Patient-Prescriber Agreement” has been updated.  View at: CLICK TO VIEW

Mar 7     Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizer’s Effexor XR® 150 Mg Extended-Release Capsules and One Lot of Greenstone’s Venlafaxine HCl 150 Mg Extended-Release Capsules Due to the Possible Presence of Tikosyn® Capsules.  Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.  This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules

Mar 5     Guidance for Industry:  CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.    You can download a copy at:  CLICK TO VIEW

Feb 28    Guidance for Industry – Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency.  
Download at:  CLICK TO VIEW

Feb 26   Drug Information Update – FDA approves Myalept to treat rare metabolic disease.  On Feb. 24, 2014, the U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.  Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin. 

Feb 26    FDA’s GDUFA Regulatory Science Initiatives Public Meeting.    FDA is hosting “The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15” Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan.   The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email ? access can register by contacting Thushi Amini (Thushi.Amini@fda.hhs.gov) by April 25, 2014. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.

Feb 24    Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.   Download this draft guidance at:  CLICK TO DOWNLOAD

Feb 24    Guidance for Industry – Analytical Procedures and Methods Validation for Drugs and Biologics.  Download this draft guidance at:  CLICK TO DOWNLOAD

Feb 18   CDERWorld is a series of educational modules based on The CDER Forum for International Regulatory Authorities Lectures.  The modules present an overview of the work of the Center for Drug Evaluation and Research. After a hiatus, CDERWorld is alive again on our website.  CDER World is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health. Please take some time to check out this excellent resource!  View at:  http://www.accessdata.fda.gov/scripts/cderworld/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 19    The slides from the meeting presentation, “FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014” are available at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM388753.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 18    Drug Information Update-FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline.  FDA has tested samples from recalled lots of Medisca’s L-citrulline product, and has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples FDA tested.  These results reinforce the FDA’s concern about Medisca’s product labeled as L-citrulline and serve to remind patients and clinics not to use any recalled Medisca L-citrulline product with lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D. 

Feb 17    MyNicKnaxs, LLC, located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction.  These products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both. At this time no illnesses or injuries have been reported to MyKnicKnaxs, LLC, in connection with these products. 

Feb 17    Ben Venue Laboratories, Inc. Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution 10%, USP,  Lot 2005479.   This voluntary recall was initiated after the discovery of a single visible glass particle in a vial within the lot listed above. There have been no complaints or adverse events related to a piece of glass in vials of this lot.

Feb 14    Public Notification - Arth-Q Contains Hidden Drug Ingredient.  The Food & Drug Administration (FDA) is advising consumers not to purchase or use Arth-Q, a product promoted & sold as a dietary supplement for joint, muscle & arthritic pain.  FDA laboratory analysis confirmed that Arth-Q contains the active ingredient, ibuprofen.

Feb 13    Introducing CDER SBIA.   Formerly known as the CDER Small Business Program, we will now be known as CDER Small Business and Industry Assistance (CDER SBIA).  CDER SBIA’s mission is to promote productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to the development and regulation of human drug products.  

Feb  11   Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Receipt Date.               
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food, Drug, and Cosmetic Act. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Standardized Study Data. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Draft Guidance for Industry on Analgesic Indications:  Developing Drug and Biological Products.                This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry and FDA Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information. 
You can download at:   CLICK TO DOWNLOAD

Feb 11    GDUFA Regulatory Science Initiatives Public Meeting and Webcast on May 16, 2014, in Silver Spring, MD.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please emailGDUFARegulatoryScience@fda.hhs.gov by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number).  

Feb 7      Guidance for Industry and Food and Drug Administration Staff - Annual Reports for Approved Premarket Approval Applications (PMA).  You can download a pdf version at:  CLICK TO DOWNLOAD 

Feb 6      FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  At this time, FDA has not concluded that FDA approved testosterone treatment increases the risk of stroke, heart attack, or death.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.  Example conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Other examples include problems with the hypothalamus and pituitary that control the testicles’ production of testosterone.  None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

 Feb 5      FDA has presented the fiscal year (FY) 2013 Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report to the President and Congress. This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.  You can read it at:  CLICK TO READ

Feb 4      The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.  Non-24 occurs in persons who are completely blind. Light does not enter their eyes and they cannot synchronize their body clock to the 24-hour light-dark cycle.  Those with the disorder may have difficulty falling asleep or staying asleep, and may wake up groggy or feeling as if they need more rest. People with non-24 may find their sleep patterns reversed -- needing to sleep during the day and to be awake at night.

Feb 3      FDA is evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Read more at:  CLICK TO READ

Jan 31    Guidance for Industry - Guidance Agenda: New & Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2014.  Download your copy at: 

CLICK TO DOWNLOAD

Jan 29    Recalls – Drugs Class II

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.   Reason:   Presence of Foreign Substance: The products are being recalled because they may contain foreign substances 

Jan 24    Improving the Quality of ANDA Submissions.  FDA is establishing a public docket to receive  input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements. Specifically, FDA is interested in hearing about difficulties sponsors are having developing and preparing their ANDA submissions.  FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry.  Improving the quality of ANDA submissions will result in more submissions accepted for filing, fewer amendments and easily correctable deficiencies (ECDs), and ultimately, more generic drug approvals.  FDA welcomes comments at any time, but we encourage submission of electronic or written comments to http://www.regulations.gov or Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 by March 24, 2014.

Jan 22    FDA/CDER Small Business Chronicles – Improving Drug Supply Chain Integrity.   The purpose of the newsletter, the FDA/CDER Small Business Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation. This newsletter is issued every other month.  Download and print your copy today:   CLICK TO DOWNLOAD

Jan 22    Recalls – Drugs Class II

Numerous incidents of gross drug product mislabeling by AidaPak Service – one example:  PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304  Reason:  Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Jan 17    FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers.   There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Jan 15    FDA is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce.  Read more in the Federal Register Notice at:  CLICK TO READ 

Jan 14    FDA announces the Availability of a draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”.  This guidance is posted at:  CLICK TO VIEW 

Specialty Pharma Newsletter - November-December 2013 

Jan 8      Recalls Class III

Cetirizine Hydrochloride Syrup, 1 mg/mL, Rx Only NDC 0603-9063-54 (120 mL bottle) and NDC 0603-9063-58 (480 mL bottle).  Distributed by Qualitest Pharmaceuticals, Huntsville, AL 35811.  Reason: Failed impurities/degradation specification – out of specification for known impurity 4-chlorobenzophenone.

G&W Fluocinolone Acetonide Cream USP 0.025% a) 15 gram (NDC 0713-0222-15) and b) 60 gram (NDC 0713-0222-60), Rx Only.  Manufactured by G&W Laboratories, Inc. South Plainfield, NJ 07080.  Reason: Failed Content Uniformity Specification at the 18 month time point.            

Jan 8      FDA approves Farxiga to treat type 2 diabetes.  The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.  Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).   An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function.

Jan 8      Guidance for Industry

Draft Guidance on Naming of Drug Products Containing Salt Drug Substances.   Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling.  You can download the draft guidance at:  CLICK TO DOWNLOAD

Guidance on Qualification Process for Drug Development Tools.  This guidance describes the qualification process for drug development tools intended for potential use, over time, in multiple drug development programs. The guidance provides a framework for interactions between FDA and sponsors to support work towards qualification of an identified drug development tool and creates a mechanism for formal review of data to qualify the tool and ensure that the evaluation is comprehensive and reliable.  A copy can be downloaded at:   CLICK TO DOWNLOAD

Draft Prescription Drug User Fee Act V Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Download a copy at:  CLICK TO DOWNLOAD   

Draft Generic Drug User Fee Act Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality, and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Get your copy at:  CLICK FOR COPY

Jan 1      Recalls – Class II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, NDC 0781-2102-01, Rx Only.  Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, N.J.  Reason:  Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin.

Carisoprodol IV (Carisoprodol Tablets USP) 350mg, RX only. Manufactured by Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked & Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 ct bottle: NDC: 54868-0816-8, 60 ct bottle: NDC: 54868-0816-4, 30 ct bottle: NDC: 54686-0816-3.  Reason:  Presence of Foreign Substance; heavy metals (chromium, titanium, etc.) and inactive components of the product were visually observed during routine stability testing. 


specialty pharma newsletter january 2013 prepared feb 11 2013 final.doc

Back to the News homepage.