Used in scans for prostate cancer with suspected metastasis. NDA 216023, held by Blue Earth. Flotufolastat F-18 Gallium.
As of Nov 13, 2026, NDA 216023 (Posluma), held by Blue Earth, was first approved by FDA on May 25, 2023, with 1 approved supplement and 0 published complete response letters.
POSLUMA 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 |
|---|---|---|---|
| May 25, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Posluma25ML (8-158mCi/ML) · solution;intravenous | Flotufolastat F-18 Gallium | RxReference drug |
| Jan 10, 2025 | Supplement 4Manufacturing · Standard review | Approved | |
| May 25, 2023 | 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
