68Ga-DOTATATE

FDA Drug Profile — NETSPOT

68Ga-DOTATATE is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including NETSPOT. Available dosage form: kit.

Drug Details

Generic Name
68Ga-DOTATATE
Brand Names
NETSPOT
Application Number
NDA208547
Sponsor
Advanced Accelerator Applications USA, Inc
NDC Codes
2
Dosage Forms
KIT
Routes
INTRAVENOUS
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )