WALTHAM, Mass.--(BUSINESS WIRE)--Repligen Corporation (NASDAQ:RGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Company’s new drug application (NDA) for SecreFlo™ for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo™ NDA.
