kit for the preparation of gallium Ga 68 gozetotide injection for intravenous use Initial U.S. Approval: 2020

kit for the preparation of gallium Ga 68 gozetotide injection) after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer

Facts about gozetotide injection

Approval Date: 2020
Proprietary Name: On Request
Active Ingredient(s): gozetotide injection
FDA-approved use: Prostate cancer
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA),
Dosage Forms and strengths: Kit for the preparation of gallium Ga 68 gozetotide injection supplied in a multiple-dose vial containing 25 mcg of gozetotide as a white lyophilized powder. After radiolabeling with gallium-68, the vial contains a sterile solution of gallium Ga 68 gozetotide at a strength up to 1,369 MBq (37 mCi) in up to 10 mL at calibration date and time.
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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