Generic Omeprazole Oral Paste Approved for Horse Gastric Ulcers
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.
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.
Archived snapshot
Apr 6, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Freedom of Information Summary – Gastrobim (omeprazole) oral paste (ANADA 200-842)
Content current as of:
04/06/2026
Regulated Product(s)
- Animal & Veterinary
Related changes
Get daily alerts for FDA CVM Veterinary Medicine Updates
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA CVM Veterinary Medicine Updates publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.