Wednesday, June 26, 2024

The Death of the American Pharmacy

 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/A7ciepe5wS4GqKZCa1TlguA

 

FDA and European Medicines Agency Announce Updates to Parallel Scientific Advice Program for New Animal Drugs

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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Tuesday, June 25, 2024

 

FDA Announces Final Guidance for Heartworm Disease Prevention Products for Dogs

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 The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized.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 The guidance announced in this notice finalizes the draft guidance dated November 30, 2022.

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Friday, June 21, 2024

 

FDA allows compounded FIP drug in certain cases

May 23, 2024 — The Food and Drug Administration recently announced that it does not intend to enforce new animal drug approval requirements for the antiviral medication ...

 

Drugmakers, compounders at odds over FDA's difficult-to- ...

13 hours ago — Drugmakers laud the US Food and Drug Administration's (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities.

 

APC: News

Jun 6, 2024 — “We have serious concerns about the Board's proposed regulations and the ongoing failure of the Board to root its regulation and enforcement of compounding in ..

 

Cal. Code Regs. tit. 16 § 1735

Jun 7, 2024 — Section 1735 - Compounding in Licensed Pharmacies (a) "Compounding" means ... Preparing a compounded drug preparation from chemicals or bulk drug substances (b) "

 

FDA alerts health care professionals, compounders and ...

Jun 5, 2024 — FDA has received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, ...

 

 

  • On Tuesday, the FDA 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. Phenylpropanolamine Hydrochloride chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as the approved brand name drug product, Proin chewable tablets, which were first approved on Aug. 4, 2011.

 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 LLCTotalTotrazuril.com and Toltrazuril Shop

 

 

 

 

 

 

 

Tuesday, June 11, 2024

 

FDA Approves First Generic Phenylpropanolamine Hydrochloride Chewable Tablets for Use in Dogs

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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