{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:zulresso", "owner": "maternal", "kind": "product", "slug": "zulresso", "name": "Zulresso (brexanolone injection)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "maternal": { "life-stage": [ "postpartum" ], "care-area": [ "maternal-mental-health" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "Brexanolone injection, 100 mg per 20 mL (5 mg/mL) solution, for continuous intravenous infusion (openFDA drugsfda product list for NDA211371)", "version": "As approved under NDA211371 (approval date 2019-06-17 under the approval letter's rule; letter signed 2019-03-19). Label text is the 2019 label. openFDA lists the product as Discontinued.", "intended_use_snapshots": [ "maternal:fda-zulresso-label-2019-2026-10-14", "maternal:fda-zulresso-label-2022-2026-10-14", "maternal:fda-zulresso-approval-letter-2019-2026-10-14" ] }, "content_digest": "3d8e0753cf62aedde9c8480324af6e20c7e7f040ee5d7de929d9e54273770fc8", "review": { "content_digest": "3d8e0753cf62aedde9c8480324af6e20c7e7f040ee5d7de929d9e54273770fc8", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-nda211371-approval", "owner": "maternal", "subject_entity_id": "maternal:zulresso", "category": "regulatory", "statement": "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.", "context": { "id": "maternal:ctx-fda-nda211371-adults-with-postpartum-depression", "label": "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_note": "Postpartum", "life_stage_terms": { "maternal": [ "postpartum" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory context)", "eligibility": { "inclusion": [ "Adults with postpartum depression" ], "exclusion": [ "Not stated in the parts of the label read for this record; see the label for contraindications and warnings" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].submissions[3].submission_public_notes", "applicability_note": "Date of approval in openFDA (Federal Register scheduling notice).", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Controlled substance scheduling, paragraph 1", "applicability_note": "The letter defines the approval date by the DEA notice.", "snapshot": { "id": "maternal:fda-zulresso-approval-letter-2019-2026-10-14", "retrieved_at": "2026-10-14T18:29:02Z", "content_hash": "8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zulresso-approval-letter-2019", "source_type": "regulator", "title": "NDA 211371 approval letter for Zulresso (brexanolone) injection", "canonical_url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "edition": "The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Paragraph 3", "applicability_note": "What the application provides for.", "snapshot": { "id": "maternal:fda-zulresso-approval-letter-2019-2026-10-14", "retrieved_at": "2026-10-14T18:29:02Z", "content_hash": "8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zulresso-approval-letter-2019", "source_type": "regulator", "title": "NDA 211371 approval letter for Zulresso (brexanolone) injection", "canonical_url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "edition": "The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Signature page", "applicability_note": "Signature date of the approval letter.", "snapshot": { "id": "maternal:fda-zulresso-approval-letter-2019-2026-10-14", "retrieved_at": "2026-10-14T18:29:02Z", "content_hash": "8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zulresso-approval-letter-2019", "source_type": "regulator", "title": "NDA 211371 approval letter for Zulresso (brexanolone) injection", "canonical_url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "edition": "The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[3].submission_status_date", "applicability_note": "Original submission action date in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].application_number", "applicability_note": "Application number in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].products[0].brand_name", "applicability_note": "Brand name in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].products[0].active_ingredients[0].name", "applicability_note": "Active ingredient in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].products[0].marketing_status", "applicability_note": "Marketing status in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda211371-2026-10-14", "retrieved_at": "2026-10-14T18:20:38Z", "content_hash": "a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda211371", "source_type": "regulator", "title": "openFDA drugsfda record for NDA211371", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA211371%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA211371", "normalized_value": "NDA211371", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "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.", "reuse_basis": "openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section 1, Indications and usage", "applicability_note": "Indication in the 2019 label.", "snapshot": { "id": "maternal:fda-zulresso-label-2019-2026-10-14", "retrieved_at": "2026-10-14T18:26:35Z", "content_hash": "ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zulresso-label-2019", "source_type": "label", "title": "ZULRESSO (brexanolone) injection prescribing information, 2019 label", "canonical_url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "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.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section 2.2, Recommended dosage", "applicability_note": "Infusion described in the 2019 label.", "snapshot": { "id": "maternal:fda-zulresso-label-2019-2026-10-14", "retrieved_at": "2026-10-14T18:26:35Z", "content_hash": "ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zulresso-label-2019", "source_type": "label", "title": "ZULRESSO (brexanolone) injection prescribing information, 2019 label", "canonical_url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (Drugs@FDA)", "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.", "reuse_basis": "FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. 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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.", "context": { "id": "maternal:ctx-brexanolone-trials-ppd-women-18-45", "label": "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). 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