Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
February 29
FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19 Diagnostic Tests.The U.S. Food and Drug Administration (FDA) issued the immediately in effect guidance titled, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Click on guidance title above to read it.
February 28
FDA Approves the First Generic of Daraprim  The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).   Toxoplasmosis is an infection caused by a single-celled parasite called Toxoplasma gondii that, when severe, can cause damage to the brain, eyes or other organs. A Toxoplasma infection can occur, among other ways, by eating undercooked, contaminated meat or shellfish; drinking water contaminated with Toxoplasma; or by accidental swallowing of the parasite through contact with cat feces that contain Toxoplasma. It is considered to be the leading cause of death attributed to foodborne illness in the United States.
February 27
Coronavirus (COVID-19) Supply Chain Update   Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China.  Also, as part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China. We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs. We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way.

Ranitidine Hydrochloride Capsules by American Health Packaging: Recall Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)   This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by American Health Packaging.   NDMA is classified as a probable human carcinogen, a substance that can cause cancer.  There have been no reports of injury or adverse events to date.
February 26
FDA approves neratinib (NERLYNX, Puma Biotechnology, Inc.) for metastatic HER2-positive breast cancer   It is to be used in combination with capecitabine in adult patients who have received two or more anti-HER2 based regimens in the metastatic setting.   Patients are treated until disease progression or unacceptable toxicity.
February 25
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing.
February 24
FDA approves first generic of ProAir HFA   The FDA has approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.   Metered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery.   As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval.   Bronchospasms occur when the muscles surrounding the airways swell and tighten, squeezing the airways and making them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. 

Med Man Expands Voluntary Nationwide Recall of Up2 to include all lots of Bow & Arrow  FDA laboratory analysis has found Up2 Dietary supplement and Bow and Arrow to contain undeclared sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 and Bow and Arrow products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

Sign-up to Receive CDC's New COVID-19 "What's New" Weekly Update    We would like to share with you CDC's new COVID-19 "What's New" weekly E-Newsletter that is being launched this week.  We invite you to sign up to receive these weekly updates, delivered right to your inbox every Monday, so you can stay current with this rapidly evolving situation.   To receive weekly up-dates mouse click on the blue "sign up" above and enter your email address.

Today the FDA Released the Enhanced Purple Book Database. The enhancement of the  "Purple Book: Database of FDA-Licensed Biological Products" (Purple Book), transitioning the current table format "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," to a searchable, public-facing online database. The first phase of the new Purple Book database will provide the public with information about FDA-licensed biological products, including biosimilar and interchangeable products, through a dynamic, accessible, easy-to-use online search engine.
February 21
FDA launches new resource to provide easily accessible, more accurate historical drug approval data.  FDA is launching a new resource to assist external and agency researchers collecting historical information about FDA's drug approvals. The Compilation of Center for Drug Evaluation and Research (CDER) New Molecular Entity (NME) Drug and New Biologic Approvals is a .CSV file available on the agency's website that will provide researchers with curated data regarding drug products approved by CDER between January 1, 1985, and December 31, 2019.

The FDA Has Released a Final Guidance for Industry, "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry (Revision 7)" after the draft version was released in July 2019. The final guidance specifies that all Type III drug master files (DMFs) will qualify for an exemption from submission in Electronic Common Technical Document (eCTD) format. This is in addition to the current exemption for noncommercial investigational new drugs (INDs).  The eCTD is the standard format for submitting applications, amendments, supplements and reports to CDER and CBER. Please visit this FDA webpage for more information on the eCTD requirement process and this webpage for more information on DMFs.
February 19
FDA Drug Safety Podcast: FDA requests the withdrawal of the weight-loss drug lorcaserin (BELVIQ, BELVIQ XR, Eisai Inc) from the market.   Reason: a safety clinical trial shows an increased occurrence of cancer.   The trial was conducted in 12,000 patients over 5 years and found that during the course of the trial, 462 or 7.7 percent of patients treated with lorcaserin were diagnosed with cancer compared to the placebo group, in which 423 or 7.1 percent of patients were diagnosed with cancer. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.  To hear the podcast Control/Click on Listen .

Warning Letters
Seven Companies Have Received Warning Letters for Marketing Unapproved and Misbranded Products Related to the Coronavirus Disease (COVID-19). They are:
Click on any of the above to read the company's Warning Letter.
February 18
FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products   The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers through the international mail system over the course of an operation that took place in January.  Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe, or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain.

2019 GDUFA Science and Research Report Today, the Food and Drug Administration (FDA) published the Fiscal Year 2019 (FY2019) GDUFA Science and Research Report. The Generic Drug User Fee Amendments of 2012 (GDUFA) established a formal regulatory science program and funded research activities for investigating new methodologies and tools for development of generic drugs. GDUFA was reauthorized in 2017 through 2022 (GDUFA II), and this report elaborates on the results of these efforts during FY2019, which marks the second year of GDUFA II. Research activities follow the FY2019 GDUFA Regulatory Science Priority Initiatives, which fall broadly into the following categories:
* Complex active ingredients, formulations, or dosage forms
* Complex routes of delivery
* Complex drug-device combination products
* Tools and methodologies for bioequivalence and substitutability evaluation
Research activities support our regulatory advice and decision-making across the generic drug program. In FY2019, we provided industry with 252 new and revised Product-Specific Guidances (PSGs) as a roadmap for generic drug development.
February 14
FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process.    The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain;  Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use.  Voltaren Arthritis Pain is a nonsteroidal anti-inflammatory drug (NSAID) and works by reducing substances in the body that cause pain and inflammation. This product, previously referred to as Voltaren Gel 1%, has been available in Europe for years and was first approved by the FDA in 2007 as a prescription drug and was indicated for the relief of the pain of osteoarthritis of joints responsive to topical treatment, in particular, the joints of the hands, knees and feet. It has not been shown to work for strains, sprains, bruises or sports injuries.
February 7
Recently Posted Guidance Documents
2/5/2020 - Withdrawn CDER Product Specific Guidances :
Butenafine Hydrochloride (Draft), Topical Cream, Ref Listed Drug 21408, Withdrawn Feb 1, 2015
Levonorgestrel (Draft), IUD, Reference Listed Drug 203159, Withdrawn Oct 1, 2014
February 5
Products Found to Have Hidden Drug Ingredients
* OrgaZEN Gold 5800 contains hidden drug ingredient : sildenafil (Viagra active)
* Alpha-Male contains hidden drug ingredients : sildenafil and tadalafil (Cialis active)
CDER Meetings, Conferences & Workshops - March 2020

Public Health Alert Concerning Dietary Supplements Containing Cesium Salts. The FDA is warning consumers to avoid using dietary supplements containing cesium chloride or any other cesium salt (collectively referred to as "dietary supplements containing cesium salts") due to significant safety risks, including heart toxicity and potential death. The FDA is also alerting health care professionals of the risks associated with dietary supplements containing cesium salts. Cesium salts have never been proven to be safe and effective to treat cancer or for any other use.