The U.S. Food and Drug Administration sent a second batch of warning letters to equine companies who are allegedly marketing their horse ulcer products without first securing federal approval.
The FDA sent letters to Abler, Inc., Cox Veterinary Laboratory, Inc., and Multivet USA, Inc. The companies are accused by the government agency of marketing gastric ulcer products as “intended for the use in the mitigation, treatment, or prevention of disease in animals,” which under the law makes their products a drug. None obtained FDA approval, a violation of Section 501 and 512 the FD&C Act.
Up to 60% of show horses, as well as non-performance horses, are affected by equine gastric ulcers, according veterinary experts.
Abler, Inc’s warning letter discusses the products AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen. The FDA states the referenced products are only a sampling of the “violative products” the company is marketing.
Testing by the FDA of AbGard revealed the amount of the active ingredient, omeprazole, did not correspond with the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim. The FDA states the drug is adulterated.
Cox Veterinary Laboratory, Inc’s warning letter is regarding the marketing of the
product Gastroade Xtra. Additionally, testing of the product revealed it is also adulterated, according to the FDA. The company’s warning letter states the active ingredient, omeprazole, in Gastroade Xtra is sub-potent, at 36.3% of the label claim for potency.
Multivet USA, Inc’s product Gastro37 OTC was also found to be sub-potent, at 82.8% of the label’s claim for potency, according to the FDA.
The companies have 15 days to respond to the FDA regarding their compliance status.
Last week, three Florida companies that market equine ulcer drugs received similar warning letters.