Napo Pharmaceuticals, Inc. Release: FDA Grants PDUFA Date of June 5, 2012 for Crofelemer

Published: Feb 08, 2012

SAN FRANCISCO--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc. (“Napo”) announced today that the New Drug Application (“NDA”) submitted on December 5, 2011 for crofelemer for the indication of chronic diarrhea in people living with HIV/AIDS on anti-retro viral therapy (“CRO-HIV”) was accepted for filing by the U.S. Food and Drug Administration (“FDA”) with a Priority Review designation. The FDA has set June 5, 2012, as the action date for the NDA under the Prescription Drug User Fee Act (“PDUFA”).

Back to news