Used in scans for suspected prostate cancer recurrence and non-informative bone scintigraphy. NDA 203155, held by Mcprf. Choline C-11.
As of Nov 13, 2026, NDA 203155 (Choline C-11), held by Mcprf, was first approved by FDA on Sep 12, 2012, with 6 approved supplements and 0 published complete response letters.
Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Choline C-114-33.1mCi/ML · injectable;intravenous | Choline C-11 | RxReference drug |
| Sep 9, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Oct 28, 2015 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 30, 2015 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Nov 16, 2014 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Oct 30, 2013 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jul 26, 2013 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 12, 2012 | 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
