Generic Omeprazole Oral Paste Approved for Horse Gastric Ulcers

FDA CVM Veterinary Medicine Updates

Published April 6th, 2026

Detected April 6th, 2026

Summary

The FDA approved Gastrobim (omeprazole) oral paste as a generic equivalent to Gastrogard for the treatment and prevention of gastric ulcers in horses and foals four weeks of age and older. Sponsored by Bimeda Animal Health Ltd. of Ireland, the drug was determined bioequivalent to the brand-name product approved in 1999. Gastrobim is available only by prescription from a licensed veterinarian.

View original document View source feed page

What changed

The FDA Center for Veterinary Medicine approved Gastrobim (omeprazole) oral paste under ANADA 200-842 as a generic version of Gastrogard for equine gastric ulcer treatment. The new drug contains the same active ingredient and was found bioequivalent to the reference listed drug. The approved indication covers both treatment of active gastric ulcers and prevention of recurrence in horses and foals.

Veterinarians prescribing Gastrobim should note the dosing protocol: 1.8 mg/lb (4 mg/kg) once daily for four weeks for treatment, continuing at 0.9 mg/lb (2 mg/kg) for at least four additional weeks for recurrence prevention. The drug is prescription-only and requires no additional compliance measures beyond standard veterinary pharmaceutical regulations. No penalties or enforcement actions are associated with this approval notice.

Source document (simplified)

April 6, 2026

The U.S. Food and Drug Administration has approved Gastrobim (omeprazole) oral paste for the treatment of gastric ulcers and prevention of gastric ulcer recurrence in horses and foals four weeks of age and older. Gastrobim is a proton pump inhibitor, a class of medications that act by blocking the pumps in the stomach lining that release stomach acid.

Gastrobim contains the same active ingredient (omeprazole) as the approved 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 a day 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).

Gastrobim is sponsored by Bimeda Animal Health Ltd. of Ireland.

Additional Information