ARCA is currently developing Gencaro™ (tradename pending FDA approval) (bucindolol hydrochloride) for the treatment of chronic heart failure. ARCA’s New Drug Application for Gencaro was accepted for filing by the U.S. Food and Drug Administration in September, 2008, and is currently under review by the FDA, with a prescription drug user fee act (PDUFA) date of May 31, 2009.
