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FDA Approves Gastrobim, First Generic Omeprazole Paste for Gastric Ulcers in Horses

Sponsored by Bimeda, Gastrobim has already been 'widely adopted' in Canada and Europe.

The U.S. Food and Drug Administration has announced its approval of Gastrobim (omeprazole) oral paste for the treatment of gastric ulcers and prevention of gastric ulcer recurrence in horses and foals 4 weeks of age and older.

Gastrobim is a proton pump inhibitor. This is a class of medications that act by blocking the pumps in the stomach lining that release stomach acid.

Available by prescription

Gastrobim contains the same active ingredient (omeprazole) as the brand-name drug product, Gastrogard, which was approved in 1999. The FDA determined that Gastrobim is bioequivalent to the brand-name product.

Gastrobim is available only by prescription from a licensed veterinarian.

For the treatment of gastric ulcers, Gastrobim should be administered orally once daily for four weeks at the recommended dosage of 1.8 mg/lb. body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional four weeks by administering Gastrobim at the recommended daily maintenance dose of 0.9 mg/lb. (2 mg/kg).

An ‘apple-flavored alternative’

Gastrobim is sponsored by Bimeda Animal Health Ltd. of Ireland. In a corresponding news release, Bimeda stated the following:

“Launched in 2022, Gastrobim has quickly become the fastest-growing omeprazole product in Canada and Europe. Widely adopted and well-reviewed by veterinarians and horse owners, it is recognized for its proven efficacy in treating and healing gastric ulcers, establishing it as a trusted therapeutic option globally.

“‘We are thrilled to introduce Gastrobim to the U.S. market,’ said Eric Moore, DVM, Bimeda’s head of Technical Services North America. ‘Gastric ulcers remain one of the most common and performance-limiting conditions in horses. Offering a bioequivalent, rigorously tested treatment underscores our commitment to supporting equine health, welfare and performance at an affordable price.’

“Equine Gastric Ulcer Syndrome affects a significant percentage of performance horses and can lead to reduced appetite, behavioral changes, discomfort and diminished athletic output. By providing a bioequivalent, apple-flavored alternative to the market, Bimeda aims to expand access to effective treatment and support improved outcomes across the entire equine industry.”