Treats spinal muscular atrophy (SMA). NDA 213535, held by Genentech Inc. Risdiplam.
As of Nov 13, 2026, NDA 213535 (Evrysdi), held by Genentech Inc, was first approved by FDA on Aug 7, 2020, with 13 approved supplements and 0 published complete response letters.
EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2024 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2023 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Evrysdi0.75MG/ML · for solution;oral | Risdiplam | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2026 | Supplement 18Labeling · Standard review | Approved | |
| Feb 10, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Jan 21, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Jan 21, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Feb 11, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Sep 17, 2024 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Feb 29, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Oct 3, 2023 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2023 | Supplement 8Manufacturing | Approved | |
| Sep 21, 2022 | Supplement 6Labeling · Standard review | Approved | |
| May 27, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Aug 7, 2020 | 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
