For Parkinson's disease (PD) experiencing "off" episodes. NDA 207145, held by Mdd US. Safinamide Mesylate.
As of Nov 13, 2026, NDA 207145 (Xadago), held by Mdd US, was first approved by FDA on Mar 21, 2017, with 3 approved supplements and 0 published complete response letters.
XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 21, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XadagoEQ 50MG BASE · tablet;oral | Safinamide Mesylate | RxReference drug |
| XadagoEQ 100MG BASE · tablet;oral | Safinamide Mesylate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Nov 25, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Jun 16, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Mar 21, 2017 | 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
