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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
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