Treats postpartum depression (PPD). NDA 217369, held by Biogen. Zuranolone.
As of Nov 14, 2026, NDA 217369 (Zurzuvae), held by Biogen, was first approved by FDA on Aug 4, 2023, with 2 approved supplements and 0 published complete response letters.
ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Zurzuvae20MG · capsule;oral | Zuranolone | RxReference drug |
| Zurzuvae25MG · capsule;oral | Zuranolone | RxReference drug |
| Zurzuvae30MG · capsule;oral | Zuranolone | RxReference drug |
| Apr 20, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Jul 31, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Aug 4, 2023 | 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
