Shire: FDA To Review SNDA To Extend Indication Of GATTEX - Quick Facts

(RTTNews) - Shire plc (SHPG, SHP.L) announced the U.S. FDA has accepted for filing the supplemental new drug application to extend the indication of GATTEX (teduglutide) for Injection to pediatric patients with Short Bowel Syndrome who are dependent on parenteral support.

GATTEX is a prescription medicine indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on parenteral support. Shire submitted the supplemental new drug application to the U.S. FDA on September 11, 2018. The FDA is expected to reach a decision in March 2019.