# Zulresso (brexanolone injection)

Product · id `maternal:zulresso` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

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Browse, life stage: Postpartum  
Browse, care area: Mental health  

## In plain language

A medicine given as a continuous drip into a vein over 60 hours, with a health care provider on site, to treat postpartum depression. FDA approved it in 2019 for adults, and a 2022 label update extended the labelled use to patients 15 years and older. The 2019 label has a boxed warning for excessive sedation and sudden loss of consciousness. openFDA now lists it as discontinued.

## Technical summary

US NDA211371. The approval letter was signed on 2019-03-19 and defines the date of approval as the date of the DEA scheduling notice, which openFDA gives as 2019-06-17; the atlas records the decision on 2019-06-17 and keeps both dates. Brexanolone injection 100 mg per 20 mL (5 mg/mL) solution for intravenous use (openFDA drugsfda). The 2019 label, which FDA marks as possibly not the latest approved, describes a 60-hour infusion with titration to a target of 90 µg/kg per hour and names Studies 1 and 2 as NCT02942004 and NCT02942017. openFDA lists the marketing status as Discontinued and gives no date or reason. The recipient is the postpartum woman: adults in the 2019 label and patients 15 years and older in the 2022 label.

## Claims, with the population each applies to

## Context: Women aged 18 to 45 years, up to 6 months post partum, with moderate to severe postpartum depression, 60-hour infusion (2018 trials)

Recipient: Maternal; Population: Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.; Care setting: 30 clinical research centres and specialised psychiatric units (abstract).; Geography: United States; Life stage: Up to 6 months post partum at screening, aged 18 to 45 years.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Followed until day 30; primary endpoint at 60 hours (abstract).

### FDA's 2019 label for Zulresso, which words the indication as adults, says its efficacy in postpartum depression was shown in two multicenter, randomized, double-blind, placebo-controlled studies in women aged 18 to 45, where a 60-hour continuous intravenous infusion or placebo was followed by 4 weeks of follow-up. Study 1 (NCT02942004) included severe postpartum depression and Study 2 (NCT02942017) moderate postpartum depression. In both, the label says titration to a target dose of 90 µg/kg per hour was superior to placebo in improvement of depressive symptoms. The published abstract of these two trials reports average HAM-D falls at 60 hours of 17.7 and 14.6 points with the 90 µg/kg dose against 14.0 and 12.1 with placebo.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.; Care setting: 30 clinical research centres and specialised psychiatric units (abstract).; Geography: United States; Life stage: Up to 6 months post partum at screening, aged 18 to 45 years.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Followed until day 30; primary endpoint at 60 hours (abstract).
- Limitations: This claim rests on the 2019 label, which FDA marks as possibly not the latest approved, and on the abstract of the Lancet paper, which has an erratum that was not read. The label states p values but this record uses only the label's qualitative statement. openFDA lists Zulresso as discontinued; this claim describes trial efficacy, not current availability. Efficacy in a trial is not a prediction for one person.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 1, Indications and usage. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: Labelled indication.
  2. Supports: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 14, Clinical studies, paragraph 1. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: The label ties Study 1 to NCT02942004.
  3. Supports: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 14, Clinical studies, paragraph 3. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: The label statement of efficacy.
  4. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 30303081). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1016/S0140-6736(18)31551-4>
     Locator: Abstract, FINDINGS, sentence 3, fragment 1 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5.
     How it applies: Published numbers, study 1.
  5. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 30303081). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1016/S0140-6736(18)31551-4>
     Locator: Abstract, FINDINGS, sentence 3, fragment 2 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5.
     How it applies: Published numbers, study 1, continued.
  6. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 30303081). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1016/S0140-6736(18)31551-4>
     Locator: Abstract, FINDINGS, sentence 4, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5.
     How it applies: Published numbers, study 2.
  7. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 30303081). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1016/S0140-6736(18)31551-4>
     Locator: Abstract, FINDINGS, sentence 4, fragment 2 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5.
     How it applies: Published numbers, study 2, continued.
  8. Background: ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7) (Label, edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211371s007lbl.pdf>
     Locator: Section 1, Indications and usage. Retrieved 2026-10-14T19:11:05Z. Source state: Current. Snapshot hash: e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed.
     How it applies: The 2022 label widens the labelled use to patients 15 years and older.
  9. Background: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 2.2, Recommended dosage. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: Dosing described in the label.
  10. Background: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Page footer. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: FDA note on the label page.
  11. Background: Department of Error (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. This is a published erratum (a correction notice). PubMed holds no abstract for it; only its bibliographic record was read.) <https://doi.org/10.1016/S0140-6736(18)32288-8>
     Locator: PublicationType. Retrieved 2026-10-14T18:19:05Z. Source state: Current. Snapshot hash: f9ce582c029e3bf4f17f8b46958e775934edf799758e47e97f7306dd24e0bd16.
     How it applies: PubMed lists a published erratum for the Lancet paper (PMID 30303081). It was not read.

## Context: Adults with postpartum depression (2019 labelled use of Zulresso, United States)

Recipient: Maternal; Population: Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.; Care setting: Healthcare setting with continuous monitoring (2019 label, dosage and administration).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context)

### FDA approved Zulresso (brexanolone) injection under NDA211371. The 2019 label words the indication as the treatment of postpartum depression in adults. A 2022 efficacy supplement (supplement 7, status date 2022-06-16 in openFDA) changed the labelled use to patients 15 years and older. The approval letter was signed on 19 March 2019; it says that because scheduling under the Controlled Substances Act was not yet complete, the date of approval is the date the DEA publishes its scheduling notice, and openFDA gives that date as 17 June 2019. The label describes a continuous intravenous infusion over a total of 60 hours. openFDA lists the product as discontinued.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.; Care setting: Healthcare setting with continuous monitoring (2019 label, dosage and administration).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context)
- Limitations: An approval is an FDA decision about a product, not a recommendation to use it for any person. The atlas treats 17 June 2019 as the decision date because the letter defines the date of approval that way; openFDA also lists an original-submission action date of 19 March 2019 (the letter's signature date). openFDA gives no date or reason for the discontinuation, so none is stated here. The label read is the 2019 label, which FDA marks as possibly not the latest approved; later supplements exist in openFDA and were not read. openFDA says its data is unvalidated.
- Last checked: 2026-10-14
- Sources:
  1. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].submissions\[3\].submission\_public\_notes. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Date of approval in openFDA (Federal Register scheduling notice).
  2. Supports: NDA 211371 approval letter for Zulresso (brexanolone) injection (Regulator, edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf>
     Locator: Controlled substance scheduling, paragraph 1. Retrieved 2026-10-14T18:29:02Z. Source state: Current. Snapshot hash: 8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7.
     How it applies: The letter defines the approval date by the DEA notice.
  3. Supports: NDA 211371 approval letter for Zulresso (brexanolone) injection (Regulator, edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf>
     Locator: Paragraph 3. Retrieved 2026-10-14T18:29:02Z. Source state: Current. Snapshot hash: 8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7.
     How it applies: What the application provides for.
  4. Supports: NDA 211371 approval letter for Zulresso (brexanolone) injection (Regulator, edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf>
     Locator: Signature page. Retrieved 2026-10-14T18:29:02Z. Source state: Current. Snapshot hash: 8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7.
     How it applies: Signature date of the approval letter.
  5. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].submissions\[3\].submission\_status\_date. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Original submission action date in openFDA.
  6. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Application number in openFDA.
  7. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Brand name in openFDA.
  8. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].products\[0\].active\_ingredients\[0\].name. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Active ingredient in openFDA.
  9. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].products\[0\].marketing\_status. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Marketing status in openFDA.
  10. Supports: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 1, Indications and usage. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: Indication in the 2019 label.
  11. Supports: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Section 2.2, Recommended dosage. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: Infusion described in the 2019 label.
  12. Background: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf>
     Locator: Page footer. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4.
     How it applies: FDA note on the label page.
  13. Supports: ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7) (Label, edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211371s007lbl.pdf>
     Locator: Section 1, Indications and usage. Retrieved 2026-10-14T19:11:05Z. Source state: Current. Snapshot hash: e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed.
     How it applies: The 2022 label wording of the indication.
  14. Supports: openFDA drugsfda record for NDA211371 (Regulator, edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application\_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application\_number found the record. The product is listed with marketing status Discontinued.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22>
     Locator: results\[0\].submissions\[8\].submission\_status\_date. Retrieved 2026-10-14T18:20:38Z. Source state: Current. Snapshot hash: a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52.
     How it applies: Status date of supplement 7 in openFDA.
  15. Background: ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7) (Label, edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.) <http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211371s007lbl.pdf>
     Locator: Highlights, last line. Retrieved 2026-10-14T19:11:05Z. Source state: Current. Snapshot hash: e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed.
     How it applies: Revision date of the 2022 label.

## Guidance, authorization and access

### Regulatory decision `maternal:regdec-fda-nda211371`

- Product: Zulresso (brexanolone injection) (`maternal:zulresso`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2019-06-17
- Product version: ZULRESSO (brexanolone) injection 5 mg/mL, NDA211371
- Pathway: NDA
- Submission: NDA211371
- Indication: Treatment of postpartum depression (PPD) in adults, as the 2019 label words the indication.
- Jurisdictions: United States; note: United States. The approval letter was signed on 2019-03-19; it sets the date of approval as the date of the DEA scheduling notice, which openFDA gives as June 17, 2019.
- Applies to: Recipient: Maternal; Population: Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.; Care setting: Healthcare setting with continuous monitoring (2019 label, dosage and administration).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context)
- Basis: claim `maternal:claim-fda-nda211371-approval`

## Connected pages

- Active ingredient: Brexanolone (`maternal:brexanolone`)
- Label: two placebo-controlled studies; published HAM-D changes at 60 hours: Postpartum depression (mother) (`maternal:postpartum-depression`) [a claim, not a settled fact; see claim `maternal:claim-zulresso-ppd-efficacy` and its context]
- Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`)
- Investigated in: Brexanolone phase 3 trials (studies 202B and 202C) (`maternal:hummingbird-brexanolone-trials`)

## Provenance

Content hash: 3d8e0753cf62aedde9c8480324af6e20c7e7f040ee5d7de929d9e54273770fc8
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14