NDA 208054, held by Blue Earth. Fluciclovine F-18.
As of Nov 14, 2026, NDA 208054 (Axumin), held by Blue Earth, was first approved by FDA on May 27, 2016, with 3 approved supplements and 0 published complete response letters.
Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Axumin9-221mCi/ML · solution;intravenous | Fluciclovine F-18 | RxReference drug |
| May 21, 2021 | Supplement 34Labeling · Standard review | Approved | |
| Jan 24, 2017 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 19, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 27, 2016 | Original applicationNew molecular entity · Priority 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
