Lutetium Lu 177 dotatate

FDA Drug Profile — Lutathera

Drug Details

Generic Name
Lutetium Lu 177 dotatate
Brand Names
Lutathera
Application Number
NDA208700
Sponsor
Advanced Accelerator Applications USA, Inc
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
LUTETIUM OXODOTREOTIDE LU-177

Indications and Usage

1 INDICATIONS AND USAGE LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.