FDA Approves First Generic Pimobendan for Management of Congestive Heart Failure in Dogs

Today the U.S. Food and Drug Administration approved Pimomedin (pimobendan) chewable tablets for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

 

Reflections on Travel to Europe – Part Three

This trip finally gave me a chance to take my first train ride through the Chunnel—frankly, it was disappointing as it was already dark so there was no view going into the tunnel and there is no view at any time of the day under the ocean! The good news is that we were traveling with FDA colleagues—a real treat.

After a good night’s sleep, we visited the U.S. Mission to the European Union (EU) in Brussels, an important historic focus for the U.S.-Europe relationship. Brussels has always had a particular significance to me because my dad was in the Battle of the Bulge, centered not far from Brussels, and he was saved from capture by Belgian people in the countryside. 

We visited Ambassador Gitenstein, the U.S. Ambassador to the EU, and got a useful briefing from the mission staff representing the variety of U.S. Government agencies with posts in Brussels.

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• 2024 Compounding Quality Center of Excellence Annual Conference

 

Reflections on Travel to Europe – Part Two Our first stop on our recent European trip was London. Although the jet lag on the first day after crossing the Atlantic can be tough and the second day is often more trying, the trip was invigorating and thought provoking. The U.S. Food and Drug Administration’s Office of Global Policy and Strategy and Office of Commissioner staff did a great job arranging a busy schedule that covered multiple critical topics. We had an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response. We visited interesting and historical venues, like the Royal Academy of Medicine, for our meeting with the Medicines and Healthcare products Regulatory Agency, or MHRA, and closed with a trip to Oxford to engage with the academic clinical trials community. It was challenging to absorb the impact of Brexit on the regulatory and healthcare systems of the U.K. Prior to-Brexit, the U.K. was a significant contributor to the European Medicines Agency (EMA) and the European system of medical product and food regulation. In fact, the EMA headquarters were located in Canary Wharf in London. Post-Brexit, rather than being part of a larger system, MHRA, which regulates drugs, biologics, and devices, and the Food Standards Agency, which regulates the food used in the U.K., primarily do so on their own. This is an enormous increase in work. The other side of the coin is the potential for the U.K. system to be creative to “meet the moment” without having to reach agreement with the diverse array of countries of the European Union. We heard a variety of interesting ideas about how to create a more effective regulatory approach, including reliance upon the work of other trusted regulators to inform their work and enhance their efficiency in the face of limited resources. Read More

 

FDA Approves New Antimicrobial Drug for Cattle and Swine

Today, the U.S. Food and Drug Administration approved Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and swine. Pradofloxacin is a medically important antimicrobial in the fluoroquinolone class and may only be prescribed by a licensed veterinarian as a single injection.

Over the past several decades, the FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals are used in a manner that is consistent with principles of antimicrobial stewardship. For example, all medically important antimicrobials for animals require the authorization of a licensed veterinarian because the FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance.

 

05/14/2024	03/29/2024	Central Admixture Pharmacy Services, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Drug Products/Adulterated
05/14/2024	05/03/2024	Natuzen Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	03/01/2024	Carbon Fire, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/14/2024	04/30/2024	Grupo Quimico SRL	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	04/15/2024	Cohere Beauty	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	03/27/2024	Vintage Chemical Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	04/17/2024	Westwood Laboratories LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	04/01/2024	Seatex, LLC	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated

 

05/07/2024	03/25/2024	Juquilita Mexican Imports LLC	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
05/07/2024	04/23/2024	ISPE Produce, Inc.	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
05/07/2024	02/22/2024	Always Fresco LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)

 

05/07/2024	04/30/2024	Global Cosmetics Company Limited	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
05/07/2024	04/18/2024	APG SEVEN, INC	Division of Human and Animal Food Operations East IV	New Drug/Misbranded