Used in scans for suspected Parkinsonian syndromes (PS). NDA 200655, held by Feinstein. Fluorodopa F-18.
As of Nov 14, 2026, NDA 200655 (Fluorodopa F18), held by Feinstein, was first approved by FDA on Oct 10, 2019, with 1 approved supplement and 2 published complete response letters.
Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Sep 15, 2016 | Fluorodopa F 18Clinical / Statistical | Approved |
| Oct 22, 2013 | Fluorodopa F 18Clinical / Statistical, Good Clinical Practice (Gcp) Inspection, Product Quality | Approved |
| Fluorodopa F181-40mCi/ML · solution;intravenous | Fluorodopa F-18 | RxReference drug |
| Fluorodopa F181-40mCi/ML · solution;intravenous | Fluorodopa F-18 | RxReference drug |
| Dec 11, 2020 | Supplement 1Manufacturing | Approved | |
| Oct 10, 2019 | 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
