January 01, 2015

 

 FDA goes after unapproved equine products

​Posted Dec. 17, 2014

The Food and Drug Administration has sent nine companies warning letters for marketing unapproved equine products.

UlcerGard (omeprazole) and GastroGard (omeprazole) are the only FDA-approved animal drugs for the prevention and treatment of equine gastric ulcers. 

On Oct. 29, 2014, Multivet USA Inc., Abler Inc., Cox Veterinary Laboratory Inc., Generic Frontline Plus, Ceva Animal Health, Douglas J. Gordon, Horse Gold Inc., Horse PreRace, and Tri-Star Equine Marketing were sent warning letters citing statements from the companies that their products are “intended for use in the mitigation, treatment, or prevention of disease in animals,” which qualify them as drugs under the Federal Food, Drug, and Cosmetic Act. The FDA letter also states, “Further, these products are new animal drugs. ... To be legally marketed, a new animal drug must have an approved new animal drug application.”

The warnings apply to the marketing of Gastro37 OTC by Multivet USA; AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerOuant, and AbFen by Abler; Gastroade XTRA by Cox Veterinary Laboratory; Lomac Equine and Omaktive Oral Paste by Generic Frontline Plus; Omoguard Paste, Thiazine 100 Injection, Glucosamine 200 Injection, Gentamax 100 Injection, and Ferrocyl Injection by Ceva Animal Health; UlcerCure OTC by Gordon; GastroMax3 by Horse Gold; omeprazole oral paste, omeprazole/ranitidine oral paste, Gastrotec, Gastromax3, flunixin, Synedem, toltrazuril paste, and Super Tie Up by Horse PreRace; and Gastrotec by Tri-Star Equine Marketing. 

FDA testing also revealed that several of these products contained higher or lower concentrations of omeprazole than stated on their labels, ranging from as little as 36.3 percent to as much as 135 percent of the label claim.

The warning letters state that the firms had 15 working days to respond in writing that they had taken corrective measures. If the companies continue selling the products, the FDA could seize those products and seek injunctions. To see a copy of the letters, click here