Drug gains conditional approval to delay congestive heart failure in dogs

Pimobendan chewable tablets can now be administered to dogs to delay congestive heart failure.

In June, the Food and Drug Administration granted a conditional approval that expands the available uses of the drug, which has been approved since 2007 for management of clinical signs of congestive heart failure in dogs caused by atrioventricular valvular insufficiency or dilated cardiomyopathy. Pimobendan also has been approved for administration to dogs as a concurrent therapy along with other drugs, such as the diuretic furosemide.

On June 16, FDA officials granted Boehringer Ingelheim Animal Health USA conditional approval to market pimobendan chewable tablets containing the same dose to delay onset of congestive heart failure in dogs with stage B2 preclinical myxomatous mitral valve disease, which is characterized by moderate to loud heart murmur resulting from mitral regurgitation and cardiomegaly.

Boehringer will market the drug under two names, Vetmedin for the indications with full approval and Vetmedin-CA1 for the conditionally approved indication.

Conditional approval indicates FDA officials have seen evidence the drug is safe and has a reasonable expectation of effectiveness. That status allows a company to market a drug while collecting the remaining efficacy data needed for full approval.