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Article: FDA Panel Votes 9-0 To Support BiDil's Clearance.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
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Washington Editor
GAITHERSBURG, Md. - The FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend approval of NitroMed Inc.'s BiDil, though questions on labeling for the cardiovascular drug persisted throughout the daylong gathering as a result of a typically touchy topic - race.
That's because the Lexington, Mass.-based company is seeking clearance to market the product, a fixed combination of the generic drugs isosorbide dinitrate and hydralazine hydrochloride, for African-Americans. The application primarily was based on data from a single study developed by a hypothesis that arose from two previous trials - that BiDil ...