December 19, 2025

Today, the U.S. Food and Drug Administration supplemented the existing approval of Vetmedin (pimobendan) chewable tablets for dogs to include a new indication – to delay the onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.

Vetmedin was conditionally approved in 2022 for this new indication under the FDA’s conditional approval authority for certain new animal drugs not intended for a minor use or minor species (“expanded conditional approval”). Today’s approval is the first time the FDA has granted a full approval of an animal drug indication that was initially conditionally approved under the agency’s expanded conditional approval authority. Conditional approval allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of the drug’s effectiveness. Conditional approval is primarily for minor uses or minor species (MUMS) drugs. 

In 2018, eligibility for conditional approval was expanded beyond MUMS to include certain major uses in major species. This change was intended to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs where demonstration of effectiveness would require a complex or particularly difficult study or studies.

A conditional approval is valid for one year with the potential for up to four annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. The animal drug sponsor has five years to obtain full approval after receiving conditional approval, or the animal drug can no longer be marketed. 

After three annual renewals, the drug sponsor, Boehringer Ingelheim Animal Health USA of Duluth, Georgia, generated the necessary effectiveness data to support a full approval and submitted a supplemental new animal drug application for FDA review.

Source from FDA:https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-drug-delay-congestive-heart-failure-dogs

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