For Lewy bodies (DLB). NDA 22454, held by Ge Hlthcare Inc. Ioflupane I-123.
As of Nov 14, 2026, NDA 22454 (Datscan), held by Ge Hlthcare Inc, was first approved by FDA on Jan 14, 2011, with 5 approved supplements and 0 published complete response letters.
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).
| Nov 1, 2022 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 14, 2011 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Datscan5mCi/2.5ML (2mCi/ML) · solution;intravenous | Ioflupane I-123 | RxReference drug |
| Apr 15, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Nov 30, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Nov 1, 2022 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Sep 11, 2015 | Supplement 4Labeling · Standard review | Approved | |
| Jan 14, 2011 | 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
