Bristol Vanlev “approvable”
Executive Summary
Bristol-Myers Squibb must conduct "at least" one additional Vanlev trial in patients resistant to "multiple other antihypertensives used in combination at their highest tolerated doses," FDA says in deeming Vanlev "approvable." The request follows recommendations made by FDA's Cardiovascular & Renal Drugs Advisory Committee after Vanlev benefits were not found to outweigh risks of angioedema. Members recommended that the length of the additional study be 24 weeks, but FDA indicated that eight weeks could be sufficient (1"The Pink Sheet" July 22, p. 20). Bristol resubmitted the omapatrilat NDA in December 2001 after pulling it in April 2000...
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