First generic pimobendan chewable tablets for canine congestive heart failure receives FDA approval

Officials with the FDA have approved pimobendan chewable tablets (Pimomedin; Cronus Pharma Specialties India) for managing signs of mild, moderate, or severe congestive heart failure in dogs caused by clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimobendan chewable tablets are indicated for use with concurrent therapy for congestive heart failure 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. Left untreated, these conditions may lead to heart failure and fluid accumulation in the chest and abdomen (congestive heart failure). Pimobendan chewable tablets are an inodilator drug that allows the heart to pump blood more effectively by helping to strengthen the muscular contractions of the heart and widening the blood vessels in this organ.

MMVD occurs in many breeds of dogs, but most frequently 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.

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

Pimobendan chewable tablets 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. The drug is available as 1.25, 2.5, 5 and 10 mg oblong half-scored chewable tablets with 50 tablets per bottle and 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 (ie, morning and evening).

Reference

FDA approves first generic pimobendane for management of congestive heart failure in dogs. News release. FDA. April 25, 2024. Accessed April 26, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-pimobendan-management-congestive-heart-failure-dogs?utm_medium=email&utm_source=govdelivery