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Gencaro FDA Approval Status

FDA Approved: No
Brand name: Gencaro
Generic name: bucindolol
Company: ARCA biopharma, Inc.
Treatment for: Heart Failure

Gencaro (bucindolol) is an investigational and pharmacologically unique beta-blocker and mild vasodilator in development for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, HFREF).

Development Timeline for Gencaro

Apr 13, 2015ARCA Biopharma Receives FDA Fast Track Designation for Gencaro
Jun  1, 2009ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA
Sep 23, 2008FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma

Further information

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