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.:

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.