BiDil Approval History

  • FDA approved: Yes (First approved June 23rd, 2005)
  • Brand name: BiDil
  • Generic name: isosorbide dinitrate and hydralazine
  • 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.

FDA Approval History 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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