Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
December 31
Warning Letters
Mr. Ashok Adityan, GPT Pharmaceuticals Private Ltd., Grandhinagar Balanagar, India 500037
During our inspection our investigators observed:
1. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
3. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Mr. Charles Kasten, Owner, Cross Brands Contract Filling, LLC, Rock
During our inspection our investigators observed:
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d) (1) and (2))..
2. Your firm lacks an adequate quality control unit with adequate facilities and procedures to ensure that drugs are manufactured in compliance with CGMP regulations and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
3. Your firm failed to conduct microbiological testing before use of each lot of a component (water) with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(6)).
The company was also charged with marketing Unapproved New Drugs, because of statements limited to approved products that are intended for the diagnosis, cure, mitigation, treatment or prevention of disease appeared on the labels of ten of their products.

Mr. David Dercher, VP, Dercher Enterprises, Inc. dba Gordon Laboratories, Upper Darby, PA 19082
During our inspection our investigators observed:
1. 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 (21 CFR 211.192).
2. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).
2. 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. Your firm also failed to establish and follow adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(a) & 21 CFR 211.22(d)).
The company was also charged with marketing four misbranded and unapproved drugs.

Mr. Pankaj S. Chudgar, President & COO, LNK International, Inc. Hauppauge, NY 11788
During our inspection, our investigator observed:
1. 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 (21 CFR 211.192).
2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
December 23
FDA Approves First Generics of Eliquis. The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.  The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc. Please contact the manufacturers for information about the medicine's availability.

FDA Approves New Treatment for Adults With Migraine.  The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.  The most common side effects that patients in the clinical trials reported were nausea, tiredness and dry mouth. Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.  The FDA granted the approval of Ubrelvy to Allergan USA, Inc.
December 19
FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) When used with CNS depressants or in patients with lung problems.  These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.   Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.

Podcast - Improving Regulatory Communication Via the CDER NexGen Portal. The CDER NexGen Portal (or the "Portal" for short) has made it easier than ever for regulated industry to communicate with the FDA. Now, an applicant, prospective applicant, or authorized U.S. agent can submit, receive, review, and respond to FDA communications in real time with receipt confirmation, two-way communications, and a communication history in one convenient centralized location. The Portal also uses multi-factor authentication to ensure data security. 

December 18
Trump Administration Takes Historic Steps to Lower U.S. Prescription Drug Prices.   Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country and original intended for sale in that foreign country. Draft Guidance: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act - PDF
December 16
FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).  For more information go to this website.

The U.S. Food and Drug Administration has posted a new analysis showing greater competition among generic drug makers is associated with lower generic drug prices.   The analysis looked at all drug products that had initial generic entry between 2015 and 2017 and showed that as competition increases, generic drug prices decline.

The U.S. Food and Drug Administration has issued "Qualification Process for Drug Development Tools - Guidance for Industry and FDA Staff." This draft guidance provides FDA's current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of DDT for its context of use- the defined boundaries within which the available data justifies use of the DDT(s)-across multiple drug development programs.
December 13
FDA approves use of drug (Vascepa) to reduce risk of cardiovascular events in certain adult patient groups.   The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease. Patients are advised to continue physical activity and maintain a healthy diet.  Vascepa is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Statins are drugs used to treat elevated cholesterol levels and reduce the risk of cardiovascular events.   

Webinar:  What's New with Forms FDA 3542a and 3542.  This webinar describes the recent updates made to Forms FDA 3542a and 3542, which NDA applicant holders use to submit patent information to FDA. Certain patent information provided by the NDA holder is published in the Orange Book. The updates we made are intended to:  reduce time to complete and process forms, update certain form fields to prevent common errors, and provide technical fixes to streamline form completion.  In addition to explaining these changes, the webinar will provide you with an in-depth overview of the forms and answers to commonly asked questions.   Click here.

FDA Updates List of Off-Patent, Off Exclusivity, Drugs without an Approved Generic.  Today, 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 for the current update and all previous updates.  For more information on our efforts to bring more drug competition to the market and address the high cost of medicines, visit the Drug Competition Action Plan web page.
December 11
Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation's opioid crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose.  The U.S. Food and Drug Administration (FDA) is working to give more people access to naloxone in case of such an emergency. If someone you know is taking opioids, be prepared and have naloxone handy. Naloxone has saved thousands of lives. It could save even more as more people know about it and have access to it.
December 10
Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products FDA is informing the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. FDA is carefully assessing this situation along with our federal and state partners. Certain clinics across the country, including some that manufacture or market illegal "stem cell" products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. Clinics may claim that they these products do not fall under the regulatory provisions for drugs and biological products - that is simply untrue. There are currently no FDA-approved exosome products.
Patients considering treatment with exosome products in the United States should:
* Ask if the FDA has reviewed the treatment.
* Ask the clinical investigator to give you the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information.
* Sign a consent form. Because there are no approved products, patients must sign a consent form to participate in a clinical trial that requires an IND application. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign.
For more information paste this address into your browser and click here:

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a multistate outbreak of hepatitis A illnesses in Indiana, Michigan, Minnesota, Missouri, Nebraska, and Wisconsin potentially linked to fresh, conventional (non-organic) blackberries from the grocery stores Fresh Thyme Farmers Market and Woodman's Market.   Currently, traceback information shows that the berries from Fresh Thyme Farmers Market came from a distribution center that ships fresh berries to Fresh Thyme Farmers Market stores in 11 states: IA, IL, IN, KY, MI, MO, MN, NE, OH, PA, and WI.
December 5
FDA Approves First Generics of Gilenya  The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.  The most common side effects reported in the clinical trials for Gilenya include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities.  The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.