Posted by Michael Wonder on 14 Nov 2018
U.S. FDA accepts for filing Shire’s supplemental new drug application for Gattex (teduglutide [rDNA origin]) for children with short bowel syndrome
13 November 2018 - Seeking approval for the potential use of Gattex to paediatric patients builds on Shire’s decade-long commitment to addressing needs in GI diseases.
Shire announced today the U.S. FDA has accepted for filing the supplemental new drug application to extend the indication of Gattex (teduglutide [rDNA origin]) for Injection to paediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Gattex is a prescription medicine indicated for the treatment of adult patients with SBS who are dependent on parenteral support.
Shire submitted the supplemental new drug application to the U.S. FDA on 11 September 2018. The U.S. FDA is expected to reach a decision in March 2019.
