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# FDA Accepts for Review an Ironwood/Allergan sNDA for Linaclotide
- URL: https://www.fdaweb.com/fda-accepts-for-review-an-ironwood-allergan-snda-for-linaclotide/
- Published: 2016-06-09T12:00:00.000Z
- Updated: 2026-09-14T21:08:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135896

FDA has accepted for review an Ironwood Pharmaceuticals and Allergan supplemental NDA for a 72 mcg dose of linaclotide for use in treating adults with chronic idiopathic constipation (CIC). The submission is based on efficacy and safety data from a double-blind, placebo-controlled Phase 3 clinical trial involving 1,223 adult patients with CIC. The user fee target action date is expected to occur in early 2017.

If approved, the 72 mcg dose of linaclotide would provide an additional treatment option for adult patients with CIC. Linaclotide is currently approved in the U.S. as a treatment for adults with CIC in a 145 mcg capsule to be taken once per day. In addition, it is approved for treating adults with irritable bowel syndrome with constipation in a 290 mcg capsule to be taken once per day.