Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
October 30
Recently Posted Guidance Documents
October 29
CDER researchers are investigating how drug characteristics, regulatory actions, and economic factors influence whether generic drugs become available for a brand-name drug.   Control/ Click on this for more information >   A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications
October 27
KVK-Tech, Inc. Anthony Tabasso, CEO, 110Terry Drive, Newtown, PA 18940 During our last inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

2. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced. (21 CFR 211.188)

Shilpa Medicare Limited Vishnukant Bhutada, Director, Raichur 584135, Karnataka, India During our inspection, our investigators observed specific violations including, but not limited to, the following.

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 follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product including the review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192 (21 CFR 211.198(a)).

Quimica Magna de Mexico, S.A. de C.V. Jprge Varela, CEO, La Aurora 25298 Saltillo, Coah. Mexico Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic drug products labeled as Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer. The results of the FDA laboratory testing of batches of these products detained at the border demonstrate that the Datsen Hand Sanitizer drug products, declared as manufactured at your facility, and the Alcohol Antiseptic 62% Topical Solution Hand Sanitizer drug products, labeled as manufactured by your facility, are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that their strength, purity, or quality falls below that which they purport or are represented to possess.

Mr Frags, LLC Jason Weage/Jason Coral, 5598 Highbury Dr., SE, Ada, MI 49301 This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://mrfrags.com/ in October 2020. The FDA has observed that your website offers chloroquine phosphate for sale in the United States. We also reviewed the labels on these products. Based on our review, these products are adulterated. Your chloroquine phosphate products have not been approved, conditionally approved, or index listed. New animal drugs that lack the required approval or index listing are "unsafe" and "adulterated"

Medoz Pharmacy of Polk, Inc., Tushar Palan, MS, RPh, 40230 Highway 27, Davenport, FL 33837 Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician. Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.

1. Your firm's cleanroom, anteroom, and non-sterile suite contained vermin including numerous dead ants, living spiders, and a dead cockroach. In addition, a colony of dead ants was observed on (b)(4) bag containing sterile stoppers located in the unclassified area.

2. Your firm handled hazardous drug products without providing adequate containment, segregation, and cleaning of work surfaces and utensils to prevent cross-contamination.

3. Your firm's ISO 5 classified aseptic processing areas contained visibly dirty equipment and surfaces, including an ISO 5 work surface that was observed with blue stains during aseptic production.

4. Your cleanroom contained difficult to clean surfaces. Specifically, your cleanroom flooring located in front of the biological safety cabinet contained cracks.

5. Your firm's personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated. In addition, an operator exposed their bare hands within the ISO 5 work area while donning gloves in preparation for aseptic production.
6. Your firm's aseptic operator manually contacted the inner surfaces of stoppers during aseptic production.

7. Your firm's cleanrooms contained HEPA filters that were stained, contained gaps between the ceiling and the HEPA frame, and had chipping paint surrounding the ceiling frame.

8. Your firm did not use a sporicidal agent in the ISO 5 areas.

9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

The FDA published the guidance for industry entitled "Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions."   This guidance finalizes the draft guidance issued in January 2017, and provides information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA. The guidance is intended to clarify what these terms mean and how to accurately use these terms in an ANDA.   As part of the Agency’s Drug Competition Action Plan, the FDA is publishing this guidance to assist in clarifying the ANDA submission process, provide assistance to potential applicants, and ultimately expand access for patients to lower cost, high quality medicines.
October 23
FDA's approval of Veklury (remdesivir) for the treatment of COVID-19-The Science of Safety and Effectiveness   Today, FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 pounds) requiring hospitalization.  This approval does not include the entire population that had been authorized to use Veklury under a mechanism called emergency use authorization (EUA), which is not the same as approval. FDA also revised the EUA for Veklury, originally issued on May 1, 2020, to permit the drug's use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.
October 22
Recently Posted Guidance

Orange Book Event.   Orange Book: Frequently Asked Questions and Answers Webinar (November 16, 2020, 1 p.m. ET) Hosted by the CDER Division of Drug Information and featuring CAPT Kendra Stewart, Orange Book Supervisor, this webinar is intended to assist stakeholders in utilizing the Orange Book. It will address some of the most frequently asked questions that the FDA has received from interested parties regarding the Orange Book. 
Register Here: 
October 20
October 16
Webinar Registration Open:  Office of Prescription Drug Promotion - Core Launch Review Process  November 20, 2020 | 1:00 p.m. - 2:00 p.m. Eastern     This webinar is FREE.  REGISTER   The updates to the Core Launch Review process are designed to improve efficiencies, maximize use of FDA's resources, provide timely feedback to firms, and support our mission to help ensure prescription drug promotion is truthful, balanced, and accurately communicated.
October 15

The FDA removed epinephrine from the lists of drugs for temporary compounding by outsourcing facilities and state-licensed pharmacies or federal facilities not registered as outsourcing facilities during the COVID-19 public health emergency. This removal is based on increased supplies of FDA-approved epinephrine products used to treat hospitalized COVID-19 patients. The updated lists are referenced in the following guidances:

Today, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH). 
   Under the June 6, 2020 version of this EUA, a respirator was authorized if it met any of three predetermined eligibility criteria. Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators-known as Appendix A-of this EUA based on those criteria.  The FDA recognizes there is still a shortage of FFRs, and to provide additional capacity as needed, the agency is continuing the emergency use authorization of respirator models that are already included in Appendix A of this reissued EUA.
October 14
Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.  Zaire ebolavirus, commonly known as Ebola virus, is one of four Ebolavirus species that can cause a potentially fatal human disease. Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids.
October 13
The U.S. Food and Drug Administration today posted five warning letters issued to companies marketing dietary supplements containing cesium chloride  In a February 2020 public health alert, the FDA warned consumers and health care professionals to avoid using dietary supplements containing cesium salts, primarily cesium chloride. In July 2018, the FDA alerted health care professionals of significant safety risks associated with cesium chloride in compounded drugs. Cesium chloride is sometimes promoted as an alternative treatment for cancer; however, no cesium-chloride-containing products have been approved by the FDA to treat cancer or any other disease.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program    TOPIC: Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample: Letter to Health Care Providers - Recommendations in a Health Care Setting for SARS-CoV-2 Testing.  The FDA recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.    The instructions provided to patients should incorporate the following information:
1)    The entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose.
2)    At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10-15 seconds per nostril.
3)    Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose for 10-15 seconds, is not proper technique and may result in an insufficient sample.
October 2
FDA Approved Drug Combination for Treating Mesothelioma   Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. The FDA granted approval to Bristol-Myers Squibb Company.