NitroMed BiDil for heart failure
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee will meet June 16 to evaluate NitroMed's BiDil for treatment of heart failure in African-Americans. NitroMed resubmitted the BiDil NDA with new data from the African American Heart Failure Trial (A-HeFT) in December; the user fee deadline is June 23. On June 15, the committee will discuss class labeling for antihypertensive drugs based on the proximity of their data to outcome trials. The meeting will be held at the Holiday Inn in Gaithersburg, Md. beginning at 8 a.m. on both days. [Editor's note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
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