Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date

Published: Sep 26, 2007

MARIETTA, Ga.--(BUSINESS WIRE)--Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued an extension to the Prescription Drug User Fee Act (PDUFA) deadline in order to complete its review of the New Drug Application (NDA) submitted for tedisamil, an investigational compound for the treatment of recent onset atrial fibrillation or atrial flutter.

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