Ironwood Pharma: FDA Approves Revised Label For LINZESS - Quick Facts

(RTTNews) - Ironwood Pharmaceuticals, Inc. (IRWD) said the FDA approved a revised label for LINZESS modifying the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. Previously, the boxed warning and contraindication applied to all children less than 18 years of age and less than 6 years of age, respectively.

LINZESS is a once-daily capsule for the treatment of adult patients with irritable bowel syndrome with constipation or chronic idiopathic constipation.

"This label update reflects a significant milestone, and we look forward to continuing to investigate the safety and efficacy of LINZESS for children," said Michael Shetzline, chief medical officer, senior vice president and head of drug development at Ironwood.