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BiDil Approval History

FDA Approved: Yes (First approved June 23, 2005)
Brand name: BiDil
Generic name: isosorbide dinitrate and hydralazine
Dosage form: Tablets
Company: NitroMed, Inc.
Treatment for: Heart Failure

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.

Development History and FDA Approval Process for BiDil

DateArticle
Jun 23, 2005Approval BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients
Jun 16, 2005FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure
Jun 15, 2005Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug
Apr 29, 2005FDA Schedules Advisory Committee Review of BiDil
Feb  3, 2005FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date
Dec 23, 2004NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans

Further information

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