GOZETOTIDE

FDA Drug Profile — Gozellix

Drug Details

Generic Name
GOZETOTIDE
Brand Names
Gozellix
Application Number
NDA219592
Sponsor
Telix Innovations SA
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

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 )