Ironwood Pharmaceuticals: No FDA advisory meeting for NDA of Linaclotide
Ironwood Pharmaceuticals (IRWD) announced that it was informed this evening that the U.S. FDA will not schedule an advisory committee meeting in connection with the its review of the New Drug Application for linaclotide proposed for the treatment of irritable bowel syndrome with constipation and chronic constipation. On August 9, 2011, Ironwood, along with its partner Forest Laboratories (FRX), announced that they submitted the NDA for linaclotide to the FDA. Under the FDA's Prescription Drug User Fee Act, the companies anticipate action by the FDA in June, approximately 10 months from the submission date. :theflyonthewall.com
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