NDA 211371, held by Sage Therap Supernus. Brexanolone.
As of Nov 13, 2026, NDA 211371 (Zulresso), held by Sage Therap Supernus, was first approved by FDA on Mar 19, 2019, with 8 approved supplements and 0 published complete response letters.
| Jun 16, 2022 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 19, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zulresso100MG/20ML (5MG/ML) · solution;intravenous | Brexanolone | DiscontinuedReference drug |
| Jan 23, 2025 | Supplement 11REMS | Approved | |
| Oct 17, 2023 | Supplement 10REMS | Approved | |
| Mar 3, 2023 | Supplement 8REMS | Approved | |
| Jun 16, 2022 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Dec 13, 2019 | Supplement 4REMS | Approved | |
| Sep 30, 2019 | Supplement 3REMS | Approved | |
| Sep 13, 2019 | Supplement 2Labeling · Standard review | Approved | |
| May 17, 2019 | Supplement 1REMS | Approved | |
| Mar 19, 2019 | 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
