Used in scans for prostate cancer. NDA 212643, held by Univ Of Ca San Fran. Gallium Ga-68 Gozetotide.
As of Nov 13, 2026, NDA 212643 (Gallium Ga 68 Gozetotide), held by Univ Of Ca San Fran, was first approved by FDA on Dec 1, 2020, with 2 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gallium Ga 68 Gozetotide0.5-5mCi/mL · solution;intravenous | Gallium Ga-68 Gozetotide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Nov 17, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Dec 1, 2020 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
