The committee will discuss new drug applications (NDA) 20-727, proposed trade name BiDil® (hydralazine hydrochloride/isosorbide dinitrate) Tablets, (37.5 mg hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., proposed for the indication of heart failure, based on the results from the African American Heart Failure Trial (A-HeFT)
BiDil® (isosorbide dinitrate/ Manual Worcel, M.D.
hydralazine HCl): Regulatory Chief Medical Officer
Background and Introductions NitroMed, Inc.
V-HeFT I and V-HeFT II: Jay N. Cohn, M.D.
ISDN/HYD Effects in Black Professor
Patients University of Minnesota
A-HeFT: Rationale, Design Anne Taylor, M.D.
And Demographics Professor
Conclusions: From V-HeFT I Milton Packer, M.D.
To A-HeFT Professor
Questions and Answers Michael Sabolinski, M.D.
Senior Vice President of Clinical Development and
Open Public Hearing Speakers
Shomarka Omar Y. Keita, M.D., D.Phil.
of Human Services, District of
Basil Halliday, M.Sc.
Charles N. Rotimi, Ph.D.
Charmaine Royal, Ph.D.