Used in scans for prostate cancer. NDA 215841, held by Novartis. Gallium Ga-68 Gozetotide.
As of Nov 13, 2026, NDA 215841 (Locametz), held by Novartis, was first approved by FDA on Mar 23, 2022, with 1 approved supplement and 0 published complete response letters.
LOCAMETZ, 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: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2022 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LocametzN/A · powder;intravenous | Gallium Ga-68 Gozetotide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Mar 23, 2022 | Original applicationNew active ingredient · 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
