Repligen Announces FDA Grant of Priority Review for SecreFlo™ NDA

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 mo

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February 21, 2012