The Death of the American Pharmacy
Bartell’s, a beloved Seattle drugstore now owned by debt-laden Rite Aid, is closing many of its locations. Its demise is the latest symptom of a national health care crisis that hurts all of us.Read in FORTUNE: https://apple.news/
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) and the European Medicines Agency (EMA) are announcing today recent updates to the Parallel Scientific Advice (PSA) program for new animal drug products to increase harmonization and facilitate development of new products to support animal health.
The animal drug industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of drug product development. The PSA program allows for animal drug sponsors to engage in concurrent scientific conversation with both agencies, the FDA and the EMA, on key issues during the development phase of new animal drug products.
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On June 25, 2024, the FDA announced the availability of final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized.
In the final guidance, the FDA clarified the discussion and recommendations related to geographic locations, laboratory dose confirmation studies, and field effectiveness studies. The agency also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with the FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. The guidance announced in this notice finalizes the draft guidance dated November 30, 2022.
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On Tuesday, the FDA posted warning letters to four companies marketing the unapproved animal drug toltrazuril to treat conditions like coccidiosis and equine protozoal myeloencephalitis (EPM). The companies included All Things Bunnies Inc., Linessa Farms LLC, TotalTotrazuril.com and T
| All Things Bunnies, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated | ||||
| Linessa Farms, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| Premier Manufacturing Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Fancystage Unipessoal, LDA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | ||||
| Toltrazuril Shop | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated | ||||
| totaltoltrazuril.com | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| Premier Manufacturing Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | ||||
| GFA Production Xiamen Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Aqualex Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated | ||||
| Landy International | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
Today the U.S. Food and Drug Administration approved Phenylpropanolamine Hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. This is the first generic phenylpropanolamine hydrochloride chewable tablets for dogs.
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