Veterinary compounding has traditionally bridged the gap between a specific drug treatment and an available or sometimes unavailable medication. Vetmedin was developed to treat specific heart conditions in animals and has proven to be a wonderful product at that. Unfortunately, animals do not all weigh the same and therefore dosage needs become more specific as do desired dosage forms. When it comes to animals, its all about compliance! There are so many conditions that are undetectable as far as showing symptoms, but some of the ones that are easier to diagnose are heart conditions. In June of 2022, the FDA conditionally approved Vetmedin-CA1 (Pimobendan), the first indicated for delaying the onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). MMVD is a heart condition where the valve allows blood to flow back into the heart resulting in an enlarged heart (cardiomegaly). This is a heart condition that cannot go left untreated as it can lead to heart failure. The conditional approval will be for animals that have a preclinical diagnosis of MMVD, meaning a heart murmur or a slight enlargement of the heart, but do not have the clinical symptoms to be diagnosed with the actual condition. Vetmedin and Vetmedin-CA1 have the same active ingredient, Pimobendan, and the dosage is the same but the drug will be marketed differently. So what does that mean in the world of veterinary compounding? It means that once the conditional approval stage has passed, you will be able to have Pimobendan compounded and used to delay the onset of MMVD and the onset of heart failure. The animal drug sponsor has five years to get a formal approval after the initial conditional approval is granted. If an animal drug addresses a life-threatening disease or meets an unmet need, and a complex or difficult study would be required, it is eligible for a conditional approval as in this case where Vetmedin-CA1 met these criteria.
Source:
https://www.fda.gov/animal-veterinary/cvm-updates/fda-conditionally-approves-first-drug-delay-onset-congestive-heart-failure-dogs
