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Ironwood and Allergan Announce Supplemental New Drug Application for 72 mcg Linaclotide in Chronic Idiopathic Constipation Has Been Accepted for FDA Review

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Additional Relevant Details FDA has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC). The sNDA for the 72 mcg dose of linaclotide is based on efficacy and safety data from a double-blind, placebo-controlled Phase III clinical trial of 1,223 adult patients with CIC. The FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in early 2017.
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Jun 09, 2016
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Related Keywords Nda, Linaclotide, Chronic Idiopathic Constipation, Cic