FDA Helps Improve Availability of Vetmedin, a Critical Heart Drug for Dogs, in the United States

Update, October 18, 2022: Boehringer Ingelheim Animal Health, the animal drug sponsor of Vetmedin^®, reports that as of June 2022, there is a reliable supply of FDA-approved Vetmedin^® in the U.S. Foreign-authorized Vetmedin^®products are no longer being imported into the United States to address decreased availability of Vetmedin^®.

May 12, 2021

In response to a shortage of Vetmedin (pimobendan), the U.S. Food and Drug Administration does not intend to object to the temporary importation of Vetmedin capsules and Vetmedin chews by Boehringer Ingelheim Animal Health USA, Inc., from Canada, the United Kingdom and Ireland to immediately increase the availability of Vetmedin in the United States. Vetmedin is a critical medication used to treat dogs with congestive heart failure due to valvular insufficiency or dilated cardiomyopathy. There is no FDA-approved alternative to Vetmedin. This measure should help fill recent gaps in the supply of Vetmedin in the U.S.

Vetmedin capsules, chews and chewable tablets all contain the same active ingredient, pimobendan. However, there are differences in the way these products are labeled. When imported Vetmedin is distributed in the U.S., it will be accompanied by a client information sheet for pet owners with detailed information explaining the key differences in labeling between the U.S.-approved and the imported products, including the differences in dosage forms, dose, and indications.

Although the imported Vetmedin products have not been evaluated or approved by FDA, they are approved in their countries of origin and subject to those countries’ regulatory standards, including adherence to good manufacturing practices. Compounded formulations of pimobendan have not been reviewed by FDA for safety or effectiveness and may vary in quality and potency.

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.