FDA Approves First Generic Pimobendan for Management of Congestive Heart Failure in Dogs

The U.S. Food and Drug Administration approved Pimomedin (pimobendan) chewable tablets for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

MMVD and DCM are diseases in dogs where an abnormal heart valve or muscle does not allow the heart valve to close completely, impacting the ability of the heart to pump blood and resulting in an enlarged heart (cardiomegaly). If left untreated, these conditions may lead to heart failure and fluid accumulation in the chest and abdomen (congestive heart failure). MMVD occurs in many breeds of dogs. It most frequently occurs in smaller breed dogs, including Cavalier King Charles Spaniels, Yorkshire terriers, and dachshunds. Historically, DCM has been primarily linked to a genetic predisposition in certain breeds as well. Both MMVD and DCM should be diagnosed by a veterinarian based on comprehensive physical and cardiac examinations.

Pimomedin is an inodilator drug that helps to strengthen the muscular contractions of the heart and widens the blood vessels (vasodilation) in this organ. This allows the heart to pump blood more effectively.

Pimomedin contains the same active ingredient (pimobendan) in the same concentration and dosage form as the approved brand name drug product, Vetmedin, which was first approved on April 30, 2007. In addition, the FDA determined that Pimomedin contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

Pimomedin is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose MMVD and DCM and to determine whether pimobendan is an appropriate treatment.

Pimomedin is available as 1.25, 2.5, 5 and 10 mg oblong half-scored chewable tablets with 50 tablets per bottle. Pimomedin should be administered orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (i.e., morning and evening).

Pimomedin is sponsored by Cronus Pharma Specialities India Private Ltd., based in India.

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

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Posted by Liz on Apr 29 2024. Filed under Current Articles, Featured. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.