Complaints Prompted FDA Scrutiny of Equine Ulcer Products

A series of unspecified complaints prompted the U.S. Food and Drug Administration (FDA) to send warning letters to several firms the agency said were marketing equine ulcer products without its approval.
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A series of unspecified complaints prompted the U.S. Food and Drug Administration (FDA) to send warning letters to several firms the agency said were marketing equine ulcer products without its approval.

UlcerGard (omeprazole) and GastroGard (omeprazole) are the only FDA-approved products for the prevention and treatment of equine stomach ulcers.

In October, Tri-Star Equine Marketing LLC, HorsePreRace, and Horse Gold, Inc. received warning letters relative to their marketing of various equine ulcer products deemed by the FDA to be “intended for use in the mitigation, treatment, or prevention of disease in animals, which makes (them) drugs under the Federal Food, Drug and Cosmetic Act.” Under the act drugs intended for use in animals “require an approved new animal drug application unless they are generally recognized as safe and effective,” the warning letters said.

Horse Gold and HorsePreRace were both warned against the marketing of CastroMax3, while Tri-Star Equine Marketing and HorsePreRace were warned against internet marketing of Gastrotec. HorsePreRace was also warned against the internet sales of omeprazole oral paste, omegrazole/ranitidine oral paste, flunixin, Synedem, toltrazuril paste, and Super Tie Up

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Written by:

Pat Raia is a veteran journalist who enjoys covering equine welfare, industry, and news. In her spare time, she enjoys riding her Tennessee Walking Horse, Sonny.

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