GOZETOTIDE

FDA Drug Profile — Gozellix

GOZETOTIDE is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Gozellix. Available dosage form: kit.

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 )