Repligen Corp. (RGEN: Quote) announced that the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company's New Drug Application or NDA for SecreFlo for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging or MRI in patients with pancreatitis.
The SecreFlo NDA was submitted on December 21, 2011 and was granted Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2012.
In addition to priority review designation, SecreFlo has also been granted Orphan Drug status in the U.S., which qualifies Repligen to receive seven years of U.S. market exclusivity for SecreFlo, if approved.
by RTT Staff Writer
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