For Parkinson's disease (PD) experiencing "off" episodes. NDA 22075, held by Kyowa Kirin. Istradefylline.
As of Nov 14, 2026, NDA 22075 (Nourianz), held by Kyowa Kirin, was first approved by FDA on Aug 27, 2019, with 0 approved supplements and 0 published complete response letters.
NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Nourianz20MG · tablet;oral | Istradefylline | RxReference drug |
| Nourianz40MG · tablet;oral | Istradefylline | RxReference drug |
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
