Thursday, May 23, 2024

 

FDA Approves First Drug for Use in Wild Quail

Today the U.S. Food and Drug Administration issued a supplemental approval for Safe-Guard (fenbendazole) for the treatment and control of gastrointestinal worms (Aulonocephalus spp.) in wild quail. This approval provides a tool for wildlife managers to treat and control these parasites in wild quail populations. While there are currently FDA-approved drugs for use in farmed quail, this is the first animal drug approval for use in wild quail and for this indication.

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 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability

May 23, 2024; 89 FR 45663

More CVM FR Notices

 

Is your compounding pharmacy pursuing best practices?

May 3, 2024 — The best compounding pharmacies hold themselves to a higher standard. They make sure each medication is safe and effective for your patients. Molly Price, DVM, ...

 

Government bans replicas of weight loss drug Ozempic, as ...

1 day ago — The government will ban compounding pharmacists from making replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight ...

 

Department of Justice News: Covetrus Sentenced for Criminal Misbranding of Prescription Drugs

Ohio-based Company Will Pay More Than $23 Million in Fines and Forfeiture

ABINGDON, Va. – Covetrus North America LLC, a company based in Dublin, Ohio, which sells veterinary products to customers across the United States, was sentenced yesterday to one-year of probation for causing the introduction and delivery of misbranded veterinary prescription drugs into interstate commerce.

In addition, the court ordered Covetrus to pay over $23 million in criminal fines and forfeitures.

Covetrus will forfeit $21,534,091, pay $1,000,000 to the Virginia Department of Health Professions, as well as a fine of $1,000,000. In addition, Covetrus is obligated to keep in place appropriate compliance measures to prevent future violations.

 

FDA Announces Position on Use of Compounded GS-441524 to Treat FIP

Because no FDA approved drug is available to treat Feline Infectious Peritonitis in cats, the U.S. Food and Drug Administration does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

The FDA is aware of social media posts suggesting that compounded GS-441524 will be “legally” available in the United States starting June 1. The agency reminds compounding pharmacies, veterinarians and pet owners that animal drugs compounded from bulk drug substances are unapproved drugs and are not, in fact, legal. However, in GFI #256, the FDA has described certain conditions where the agency does not intend to take enforcement actions for compounded products for use in animals.

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  • On Friday, the FDA announced it had conditionally approved the first torsemide animal drug for dogs. UpCard-CA1 (torsemide oral solution) was conditionally approved for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary edema (fluid build-up in lungs) in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

 On Friday, the FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis, under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

 

Update: FDA extends comment period for new regulations for animal drug labeling

On May 21, 2024, the FDA announced it is extending the comment period for the proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs” by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Either electronic or written comments must be submitted by August 9, 2024.

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 Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period

May 22, 2024; 89 FR 44944