teduglutide

FDA Drug Profile — Gattex

Drug Details

Generic Name
teduglutide
Brand Names
Gattex
Application Number
NDA203441
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
4
Dosage Forms
KIT, INJECTION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
TEDUGLUTIDE

Indications and Usage

1 INDICATIONS AND USAGE GATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support . GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. ( 1 )