Nitromed’s BiDil Should Not Be Second-Line Therapy, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
BiDil should be indicated for first-line treatment of chronic heart failure in African American patients, FDA says in briefing material for the Cardiovascular & Renal Drugs Advisory Committee’s June 16 review of the Nitromed product. Nitromed had requested a second-line indication. BiDil would be the first drug specifically indicated for African Americans