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Ga 68 PSMA-11 FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 8, 2020.

FDA Approved: Yes (First approved December 1, 2020)
Brand name: Ga 68 PSMA-11
Dosage form: Injection
Company: University of California, San Francisco
Treatment for: Diagnosis and Investigation

Ga 68 PSMA-11 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.

Development timeline for Ga 68 PSMA-11

Dec  1, 2020Approval FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

Further information

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