Glenn Polyn//May 12, 2021//
Glenn Polyn //May 12, 2021//
Press release: U.S. Food and Drug Administration
In response to a shortage of Vetmedin (pimobendan), the U.S. Food and Drug Administration (FDA) 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 United States
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.
When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the United States and, when necessary, other countries, to find ways to resolve these shortages. FDA does not have the authority to require a company to make any product, even if it is medically necessary. Additional information and resources can be found on the FDA website.