NitroMed BiDil Heart Failure Indication For African Americans To Be Reviewed By Cmte.
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee will meet June 16 to consider the resubmitted BiDil NDA. Drug could be first approval specifically for African Americans. Committee will also meet June 15 to discuss antihypertensive class labeling.