GALLIUM GA-68 GOZETOTIDE

FDA Drug Profile — Gallium Ga-68 PSMA-11

Drug Details

Generic Name
GALLIUM GA-68 GOZETOTIDE
Brand Names
Gallium Ga-68 PSMA-11
Application Number
NDA212642
Sponsor
UCLA Biomedical Cyclotron
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
GALLIUM GA-68 GOZETOTIDE

Indications and Usage

1 INDICATIONS AND USAGE Gallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )