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# FDA Withdraws Sage’s NDA for Zulresso
- URL: https://www.fdaweb.com/fda-withdraws-sages-nda-for-zulresso/
- Published: 2025-03-17T12:00:00.000Z
- Updated: 2026-09-14T14:55:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158832

*Federal Register* notice: FDA is withdrawing approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution, 100 mg/20 mL after it told the agency that the drug product was no longer marketed and requested the withdrawal. Zulresso is indicated for treating moderate-to-severe postpartum depression. FDA says that any inventory can be dispensed until they have been depleted or the drug products have reached their expiration dates. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2025-03-14/pdf/2025-04101.pdf?ref=fdaweb.com).