Posted by Michael Wonder on 26 Aug 2021
Ironwood Pharmaceuticals announces FDA approval of revised Linzess (linaclotide) label
26 August 2021 - Ironwood Pharmaceuticals today announced that the U.S. FDA approved a revised label for Linzess (linaclotide) based on clinical safety data that has been generated thus far in paediatric studies.
The updated label modifies the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age.
