The first generic of veterinary drug pimobendan, used to manage congestive heart failure in dogs due to clinical myxomatous mitral valve disease or dilated cardiomyopathy has been approved by the U.S. Food and Drug Administration. The drug is manufactured by Cronus Pharma Specialities India Pvt Ltd, the Hyderabad-based manufacturing subsidiary of privately held U.S. veterinary drug research company Cronus Pharma based in East Brunswick, New Jersey.
The FDA on Thursday approved Pimomedin chewable tablets for the management of signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease, previously also known as endocardiosis, or dilated cardiomyopathy. Pimomedin is indicated for use with concurrent therapy for congestive heart failure (like furosemide, a diuretic drug to relieve pulmonary oedema and pleural effusion) on a case-by-case basis.
Myxomatous mitral valve disease and dilated cardiomyopathy are diseases in dogs where an abnormal heart valve or muscle does not allow the heart valve to close completely, affecting the heart’s ability 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).
Myxomatous mitral valve disease occurs in many breeds of dogs, but more frequently in smaller breeds, including Cavalier King Charles spaniels, Yorkshire terriers, and dachshunds. Historically, dilate cardiomyopathy has been primarily linked to a genetic predisposition in certain breeds as well. Both diseases 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 the 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 branded product Vetmedin, which is manufactured by German pharmaceutical company Boehringer Ingelheim. Vetmedin was first approved on April 30, 2007. The FDA also determined that Pimomedin contains no inactive ingredients that may significantly affect the bio-availability of the active ingredient.
Pimomedin can only be used by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose both heart conditions and to determine whether pimobendan is an appropriate treatment.
Pimomedin is available as 1.25 mg, 2.5 mg, 5 mg and 10 mg oblong half-scored chewable tablets with 50 tablets per bottle. It 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., in the morning and evening.
Source: PR Newswire
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