Congestive Heart Failure
FDA Issues Split Decision On New Indication For Diovan
Published in Medical Letter on the CDC and FDA, November 18th, 2001
The Cardiovascular and Renal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) has issued a four-to-four split decision about whether to recommend approval of Diovan (valsartan) for the treatment of heart failure. Advisory committees provide independent opinions and recommendations to the FDA on applications to market new drugs or approved drugs for supplemental indications. Final decisions are made by the FDA.
The supplemental new drug application (sNDA) for Diovan for heart failure was filed with the FDA on April 27, 2001, by Novartis Pharmaceuticals Corp., and was granted priority review status. The Diovan filing is based on the positive...
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