FDA Drug Approvals
BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients
BiDil is a fixed-dose combination of isosorbide dinitrate (a vasodilator) and hydralazine hydrochloride (an arterial dilator) indicated for the treatment of heart failure in black patients.Related Articles:
FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure - June 16, 2005
Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug - June 15, 2005
FDA Schedules Advisory Committee Review of BiDil - April 29, 2005
FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date - February 3, 2005
NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans - December 23, 2004
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