NitroMed BiDil Could Be First Drug Cleared Specifically For African Americans
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
NitroMed BiDil could be first drug cleared specifically for African Americans. Company plans NDA resubmission by year-end with results from African American Heart Failure Trial in response to 2001 "approvable" letter. A-HeFT data show 43% survival improvement vs. placebo. NitroMed targets launch for first-quarter 2005