- The U.S. Food and Drug Administration approved Gastrobim (omeprazole) oral paste for treating and preventing gastric ulcers in horses.
- The product is the first generic omeprazole oral paste approved for equine gastric ulcer treatment.
- Gastrobim contains the same active ingredient as the brand-name product Gastrogard and was determined to be bioequivalent.
- The medication is approved for horses and foals four weeks of age and older.
- Gastrobim is available only by prescription from a licensed veterinarian.
The U.S. Food and Drug Administration has approved Gastrobim (omeprazole) oral paste for the treatment of gastric ulcers and the prevention of gastric ulcer recurrence in horses and foals four weeks of age and older.
Gastrobim is a proton pump inhibitor that works by blocking the pumps in the stomach lining responsible for releasing stomach acid. Reducing acid production allows gastric ulcers to heal and helps prevent recurrence.
First Generic Version of Omeprazole Paste
The FDA determined that Gastrobim is bioequivalent to the brand-name equine gastric ulcer medication Gastrogard, which was originally approved in 1999. The approval makes Gastrobim the first generic omeprazole oral paste available for this indication in horses.
The product is approved for both treatment and prevention of equine gastric ulcers, a common condition in performance and racehorses.
Dosing and Administration
For treatment of gastric ulcers, Gastrobim should be administered orally once daily for four weeks at a dosage of 1.8 mg per pound of body weight (4 mg/kg).
To prevent recurrence, treatment should continue for at least an additional four weeks at a maintenance dose of 0.9 mg per pound (2 mg/kg) once daily.
Gastrobim is available only by prescription and must be dispensed by a licensed veterinarian.
The product is sponsored by Bimeda Animal Health Ltd., headquartered in Ireland.
Information sourced from the regulatory announcement.
