FDA accepts for filing Shire’s sNDA for GATTEX® (teduglutide [rDNA origin]) for SBS
Shire announced the FDA has accepted for filing the supplemental new drug application to extend the indication of GATTEX® (teduglutide [rDNA origin]) for Injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome who are dependent on parenteral support. November 13, 2018