## FREQUENTLY ASKED QUESTIONS ## FAQs Both products are produced with a formulation containing 37% w/w omeprazole. GASTROBIM™ is the only FDA authorized ANADA (Abbreviated New Animal Drug Application) omeprazole paste. As part of the required licensing process for a generic drug, bioequivalence has successfully been demonstrated between GASTROBIM™ and the pioneer product in vivo. --- **\*Note below:** The official US regulatory guidance document on bioequivalence (BE), Guidance for Industry No. 224, as quoted below, best clarifies the conditions under which two products are confirmed as being bioequivalent, with the critical detail that they are interchangeable in a clinical setting. *When using blood drug concentrations as a surrogate for demonstrating product BE, there is an underlying assumption that two products having an “equivalent” rate and extent of drug absorption, as measured in the blood, will be therapeutically indistinguishable and **therefore interchangeable in a clinical setting.” FDA-CVM GFI 224*** Although it can be easy to talk about a particular “formulation” or the uniqueness of a product, it is most important to remember the purpose of administering the product to the horse. GASTROBIM™ has been proven to be **bioequivalent** to GastroGard®. Both GastroGard® and GASTROBIM™ are designed to inhibit acid formation in the horse’s stomach Since both products have been found to be bioequivalent, they exhibit equivalent rates and extents of drug absorption. Since omeprazole must enter the bloodstream to exhibit its effect on acid-producing cells in the stomach, once omeprazole is absorbed, any differences in formulations are no longer of any relevance.: ![Omeprazole concentration versus time in horses](https://www.gastrobim.com/images/2026/04/29/gastrobim_plasmaconcentrationslide_final.gif) Regulations may vary from discipline to discipline. Please consult the governing body of your discipline (dressage, endurance, racing, etc.), for the most accurate information regarding allowable omeprazole usage in relation to competition. Yes- **Bioequivalence** studies have been carried out, in live animals, to demonstrate the levels of drug over time following treatment with the test and reference products. The pivotal pharmacokinetic parameters were determined and statistically compared, allowing bioequivalence between products to be concluded as part of the product licensing process (see earlier FDA conclusions on bioequivalence). The key study used for registration purposes involved 40 study horses receiving the test product (GASTROBIM™) on 2 occasions and the pioneer product (GastroGard®) on 2 occasions with each treatment separated by a seven-day washout period. Horses had 4 treatment periods was fully replicated, double crossover. ### Treatment for the 2 groups was as indicated below: | | Period 1 | Period 2 | Period 3 | Period 4 | |---|---|---|---|---| | Group A | Test | Pioneer | Test | Pioneer | | Group B | Pioneer | Test | Pioneer | Test | | | GASTROBIM™ | GastroGard® | Geometric Mean Ratio | |---|---|---|---| | AUC (hours\*ng/ml) (representing total systemic absorption) | 1264 | 1166 | 1.08 | | Cmax (ng/ml) (representing peak plasma concentration) | 452 | 426 | 1.06 | | Tmax (mins) (time to maximum plasma concentration) | 91.8 | 87.6 | | AUC and CMax have geometric means displayed ## COMPARISON | ### PRODUCT | ### **COMPANY** | ### **FLAVOR** | ### **PASTE** | ### **LABELED FOR TREATMENT AND PREVENTION** | ### **BODYWEIGHT TREATED PER SYRINGE** | ### **FDA APPROVAL REGISTRATION #** | |---|---|---|---|---|---|---| | ![gastrobim logo](https://www.gastrobim.com/images/2026/04/01/gastrobim-logo-white.png) | Bimeda | ![apple flavored](https://www.gastrobim.com/images/2026/04/01/apple-flavor.png) | fas fa-check | fas fa-check | 1250 lbs. | ANADA # 200-842 | | ![gastrogard logo](https://www.gastrobim.com/images/2026/04/01/gastrogard-logo.jpg) | Boehringer Ingelheim | Cinnamon | fas fa-check | fas fa-check | 1250 lbs. | NADA # 141-123 | **IMPORTANT SAFETY INFORMATION:** The safety of GASTROBIM™ paste has not been determined in pregnant or lactating mares. For use in horses and foals 4 weeks of age and older. Keep out of reach of children. In case of ingestion, contact a physician. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. ![](https://www.gastrobim.com/images/2026/04/07/fc_austria.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_belgium.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_canada.png)Bimeprazol ![](https://www.gastrobim.com/images/2026/04/07/fc_usa.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_denmark.png)Gastrobim Vet ![](https://www.gastrobim.com/images/2026/04/07/fc_estonia.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_france.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_germany.png)Bimeprazol ![](https://www.gastrobim.com/images/2026/04/07/fc_ireland.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_usa.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_italy.png)Bimeprazol ![](https://www.gastrobim.com/images/2026/04/07/fc_latvia.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_lithuania.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_netherlands.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_spain.png)Bimeprazol ![](https://www.gastrobim.com/images/2026/04/07/fc_usa.png)Gastrobim ![](https://www.gastrobim.com/images/2026/04/07/fc_sweden.png)Gastrobim Vet ![](https://www.gastrobim.com/images/2026/04/07/fc_uk.png)Bimeprazol ![](https://www.gastrobim.com/images/2026/04/07/fc_poland.png)Bimeprazol ### Over a million doses sold globally since 2024.