What is CA1?
CA1 stands for Conditional Approval-1 and denotes the first conditional approval granted by the Food and Drug Administration (FDA) for VETMEDIN® (pimobendan).
VETMEDIN-CA1 is indicated for the delay of onset of clinical signs of heart failure in dogs with B2, preclinical (asymptomatic with a systolic mitral murmur and evidence of increased heart size) myxomatous mitral valve disease (MMVD).1.
What is conditional approval?
The FDA grants conditional approval for animal drugs to treat serious, life-threatening diseases for which there are no approved therapies available. Drug safety has been demonstrated, and the drug is manufactured in accordance with full approval standards. As per the FDA, drug effectiveness is likely (ie, “reasonable expectation of effectiveness”) while full effectiveness data are being collected.
What is the difference between conditional approval and full approval?
For both conditional approval and full approval, the drug company must prove, among other things, that the animal drug is safe when used according to the label. Both VETMEDIN and VETMEDIN-CA1 have extensive data demonstrating product safety.1,3 The difference lies in the effectiveness requirement.
For full approval, the drug company must provide “substantial evidence” of the drug’s effectiveness. For conditional approval, the drug has a “reasonable expectation of effectiveness,” but has not yet proven that it meets the “substantial evidence” standard of effectiveness for full approval.
Conditionally approved animal drugs must state on the labeling: “Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-556.”
Which product should I prescribe?
Prescribe the appropriate product for the patient based on the stage of heart disease at the time of prescription (ie, VETMEDIN for Stage C or D CHF, or VETMEDIN-CA1 for Stage B2 preclinical MMVD dogs).
What presentations of VETMEDIN-CA1 are available?
1.25 mg and 5 mg oblong half-scored chewable tablets, with 50 tablets per bottle.
IMPORTANT SAFETY INFORMATION:
VETMEDIN® (pimobendan) Chewable Tablets are for use in dogs with clinical evidence of heart failure only. The most common side effects reported in field studies were poor appetite, lethargy, diarrhea, dyspnea, azotemia, weakness, and ataxia. VETMEDIN should not be given in case of hypertrophic cardiomyopathy, aortic stenosis, or any other clinical condition where an augmentation of cardiac output is inappropriate for functional or anatomical reasons. For more information, please refer to the package insert.