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Zulresso FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved March 19, 2019)
Brand name: Zulresso
Generic name: brexanolone
Dosage form: Injection
Company: Sage Therapeutics
Treatment for: Postpartum Depression

Zulresso (brexanolone) is a gamma-aminobutyric acid A (GABAA) receptor positive allosteric modulator indicated for the treatment of postpartum depression (PPD).

Development timeline for Zulresso

Mar 19, 2019Approval FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
Nov 20, 2018Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
Nov  2, 2018Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
May 30, 2018Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
Apr 23, 2018Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
Nov  9, 2017Sage Therapeutics Announces Brexanolone Achieves Primary Endpoints in Both Phase 3 Clinical Trials in Postpartum Depression

Further information

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