Ironwood Pharmaceuticals Announces FDA Advisory Committee Meeting Will Not be Scheduled in Connection with New Drug Application for Linaclotide

2/9/2012 6:59:50 AM

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an advisory committee meeting in connection with the its review of the New Drug Application (NDA) for linaclotide proposed for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). On August 9, 2011, Ironwood, along with its partner Forest Laboratories, announced that they submitted the NDA for linaclotide to the FDA. Under the FDA’s Prescription Drug User Fee Act (PDUFA), the companies anticipate action by the FDA in June 2012, approximately 10 months from the submission date.

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