The FDA has approved the first generic omeprazole oral paste for equine gastric ulcers, according to a dvm360 report published April 6. The article says the product, Gastrobim from Bimeda Animal Health, is approved for the treatment of gastric ulcers and for the prevention of gastric ulcer recurrence in horses and foals 4 weeks of age and older. It also says the product is available only with a veterinarian’s prescription. :contentReference[oaicite:0]{index=0}
The approval matters because it adds a new generic option in a treatment area long associated with a branded product. Dvm360 says Gastrobim is bioequivalent to Gastrogard, the brand name product from Boehringer Ingelheim that was approved in 1999. Both products contain the same active ingredient, omeprazole, which is widely used in equine medicine to reduce stomach acid. :contentReference[oaicite:1]{index=1}
FDA says the new paste is a generic version of omeprazole
The dvm360 report says Gastrobim is the first generic omeprazole oral paste approved by the FDA for horses with gastric ulcers. It describes the product as a proton pump inhibitor, a class of medicines that works by blocking the pumps in the stomach lining that release stomach acid. That mechanism is what makes omeprazole important in the management of equine gastric ulcer disease. :contentReference[oaicite:2]{index=2}
The article also says Gastrobim is bioequivalent to Gastrogard. In practical terms, that means the FDA found the generic product comparable to the brand name version in how it delivers the active ingredient. For readers who want the official federal announcement, the FDA notice is here FDA approval announcement. :contentReference[oaicite:3]{index=3}
The approved use covers treatment and prevention of recurrence
The report says the FDA approval covers two related uses. The first is treatment of gastric ulcers. The second is prevention of gastric ulcer recurrence. Dvm360 says both indications apply to horses and foals that are at least 4 weeks old, which gives veterinarians a defined age threshold for use. :contentReference[oaicite:4]{index=4}
According to the article, treatment dosing is once a day for four weeks at 1.8 mg per pound of body weight, or 4 mg per kilogram. For prevention of recurrence, the report says treatment should continue for at least an additional four weeks at a maintenance dose of 0.9 mg per pound, or 2 mg per kilogram, once daily. Those details make the approval more than a product announcement because they show exactly how the paste is meant to be used under the label. :contentReference[oaicite:5]{index=5}
Why the generic approval may matter in equine practice?
The dvm360 article presents the approval as a practical development for veterinarians managing equine gastric ulcers. A first generic product can change the treatment landscape because it gives clinicians and horse owners another prescription option in a category already familiar to the profession. The report does not speculate on pricing or market share, but the existence of a generic itself is a notable milestone. :contentReference[oaicite:6]{index=6}
The article keeps the focus on the product’s regulatory significance rather than on broader claims. It does not present the approval as changing the disease itself or as introducing a new active ingredient. Instead, it emphasizes that this is the first generic oral paste version of omeprazole approved by the FDA for this specific equine use. For broader equine animal health context in English, readers can also visit Agroinformacion. :contentReference[oaicite:7]{index=7}
What veterinarians and horse owners may watch next?
The key point from the report is that the FDA approval is now in place and that the product has a defined role in both treatment and recurrence prevention. For veterinarians, that means a new label approved generic product is available by prescription for a common equine stomach condition. For horse owners, it means there may now be another path to a product built around the same active ingredient used in the long established brand. :contentReference[oaicite:8]{index=8}
Dvm360 does not go beyond the approved use details or suggest off label applications. It stays centered on the FDA action, the generic status, and the labeled dosage schedule. The official report was published by dvm360 on April 6, 2026, based on the FDA announcement released the same day. :contentReference[oaicite:9]{index=9}