{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:curosurf",
  "owner": "maternal",
  "kind": "product",
  "slug": "curosurf",
  "name": "Curosurf (poractant alfa)",
  "aliases": [
    "Curosurf",
    "CUROSURF"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A surfactant medicine for premature babies. FDA approved Curosurf in 1999 under new drug application NDA 20-744; openFDA now lists the application as BLA020744. Its US label says it is indicated for rescue treatment of respiratory distress syndrome in premature infants, and that it reduces deaths and air leaks (pneumothorax) linked to the syndrome. It is put straight into the windpipe.",
  "summary_technical": "Product, medicine. The 1999 FDA approval letter is headed NDA 20-744, names Dey Laboratories as the applicant and says the new drug application (section 505(b)) was approved on the date of the letter. openFDA now lists the application as BLA020744 with the original submission (ORIG-1) approved on 1999-11-18, classified Type 1, new molecular entity, sponsor CHIESI USA INC; the product is CUROSURF intratracheal suspension, 80MG/ML, marketing status Prescription. Label read: openFDA label version 45, effective 2025-12-10 (the dataset copy, not the current DailyMed label). No source read states why openFDA now lists the application as a BLA. The label's dosing and clinical studies sections were not read.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn"
      ],
      "care-area": [
        "preterm-and-sick-newborn"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "CUROSURF intratracheal suspension, 80MG/ML poractant alfa (Drugs@FDA), single-dose vial (label description).",
    "version": "openFDA label version 45, effective 2025-12-10",
    "intended_use_snapshots": [
      "maternal:openfda-label-bla020744-2026-10-15",
      "maternal:openfda-drugsfda-bla020744-2026-10-15"
    ]
  },
  "content_digest": "976d251a9d03ad87b68743f6224c0aadee44f311381430deea017115df9caa45",
  "review": {
    "content_digest": "976d251a9d03ad87b68743f6224c0aadee44f311381430deea017115df9caa45",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "fc5a600ec7387e71",
      "id": "maternal:claim-curosurf-label-rds-effect",
      "owner": "maternal",
      "subject_entity_id": "maternal:curosurf",
      "category": "effect",
      "statement": "The US label for Curosurf says it is indicated for rescue treatment of respiratory distress syndrome in premature infants, and says that Curosurf reduces mortality and pneumothoraces (air leaks into the chest) associated with RDS.",
      "context": {
        "id": "maternal:ctx-fda-bla020744-us",
        "label": "Premature infants with respiratory distress syndrome, US approval and label for Curosurf (NDA 20-744, now listed as BLA020744)",
        "recipient": "newborn",
        "population": "Premature infants with respiratory distress syndrome (RDS), for rescue treatment, as the US label words the indication. The label gives no gestational age or birth weight limits in the indication text.",
        "care_setting": "Not stated in the source (the indication text does not name a setting)",
        "geography": "United States (FDA-approved labelling)",
        "life_stage_note": "Premature infants",
        "life_stage_terms": {
          "maternal": [
            "newborn"
          ]
        },
        "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": [
            "Premature infants with respiratory distress syndrome (rescue treatment)"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "guidance",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "This is the manufacturer's statement in FDA-approved labelling (openFDA copy, version 45), not a result read from a trial report: the label's clinical studies section was not read, so no numbers, comparator or follow-up are recorded. It says nothing about SUPPORT or other trials of surfactant against CPAP. The label word is rescue treatment; prophylactic use is not covered by this claim.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
        {
          "evidence_role": "supports",
          "locator": "results[0].indications_and_usage[0]",
          "applicability_note": "openFDA label record, CC0.",
          "snapshot": {
            "id": "maternal:openfda-label-bla020744-2026-10-15",
            "retrieved_at": "2026-10-15T13:51:06Z",
            "content_hash": "d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-label-bla020744",
            "source_type": "regulator",
            "title": "Curosurf prescribing information for BLA020744: openFDA drug label record",
            "canonical_url": "https://api.fda.gov/drug/label.json?search=openfda.application_number:%22BLA020744%22",
            "identifiers": [],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration (openFDA)",
            "edition": "The openFDA drug label endpoint, fetched on 2026-10-15. The wording is the dataset's copy of the label as of the date fetched, not the current DailyMed label.",
            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-label-BLA020744.json. Short quotations only.",
            "public_text": "quote",
            "replaced_by": null,
            "retirement_note": null
          }
        }
      ],
      "review": {
        "content_digest": "56a8dfaa2937ba5c3a917c98ecf89f683c0b2e0b186533160faac48ba75864e5",
        "current": [],
        "conflicting": [],
        "stale": [],
        "inactive": []
      },
      "api_path": "api/v1/claims/maternal--claim-curosurf-label-rds-effect.json"
    },
    {
      "release_id": "fc5a600ec7387e71",
      "id": "maternal:claim-fda-nda020744-curosurf",
      "owner": "maternal",
      "subject_entity_id": "maternal:curosurf",
      "category": "regulatory",
      "statement": "The 1999 FDA approval letter, headed NDA 20-744 and addressed to Dey Laboratories, approves the new drug application for Curosurf (poractant alfa) Intratracheal Suspension for the treatment (rescue) of respiratory distress syndrome in premature infants. openFDA now lists the application as BLA020744, original submission (ORIG-1) approved on 1999-11-18, classified Type 1, new molecular entity, with the sponsor CHIESI USA INC. The US label (openFDA copy, version 45, effective 2025-12-10) says Curosurf is indicated for the rescue treatment of respiratory distress syndrome in premature infants.",
      "context": {
        "id": "maternal:ctx-fda-bla020744-us",
        "label": "Premature infants with respiratory distress syndrome, US approval and label for Curosurf (NDA 20-744, now listed as BLA020744)",
        "recipient": "newborn",
        "population": "Premature infants with respiratory distress syndrome (RDS), for rescue treatment, as the US label words the indication. The label gives no gestational age or birth weight limits in the indication text.",
        "care_setting": "Not stated in the source (the indication text does not name a setting)",
        "geography": "United States (FDA-approved labelling)",
        "life_stage_note": "Premature infants",
        "life_stage_terms": {
          "maternal": [
            "newborn"
          ]
        },
        "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": [
            "Premature infants with respiratory distress syndrome (rescue treatment)"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The date is that of the original submission's action in openFDA's Drugs@FDA data; it is not the date of the current label, which has changed through many supplements. The indication wording is from the openFDA copy of the current label and was not compared with the DailyMed page. Approval means FDA found the product acceptable for the labelled use in the United States; it is not a recommendation for any baby, and labelled uses differ by country. The letter is a scanned image typed by hand, so its quotations cannot be checked by a text search. No source read states why openFDA now lists the application as a BLA.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
        {
          "evidence_role": "supports",
          "locator": "Page 1: header, paragraphs 1 and 4",
          "applicability_note": "1999 approval letter for NDA 20-744; short quotation; scanned image typed by hand.",
          "snapshot": {
            "id": "maternal:fda-nda020744-letter-2026-10-15",
            "retrieved_at": "2026-10-15T14:45:39Z",
            "content_hash": "2f27c0a9299bd0776779a3bcd310724ecd2475065641b97f6dd19b653c63801d",
            "source_effective_date": "1999-11-18",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:fda-nda020744-letter",
            "source_type": "regulator",
            "title": "FDA approval letter, NDA 20-744, Curosurf (poractant alfa) Intratracheal Suspension (1999)",
            "canonical_url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf",
            "identifiers": [],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration",
            "edition": "The 1999 approval letter PDF, fetched on 2026-10-15 from the link in the openFDA Drugs@FDA record for BLA020744. It is a scanned image with no text layer, read by eye; every quotation was typed from the page.",
            "reuse_basis": "The FDA website policies page (fetched as mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. The PDF bytes are not committed; only the hash is kept. Short quotations only.",
            "public_text": "quote",
            "replaced_by": null,
            "retirement_note": null
          }
        },
        {
          "evidence_role": "supports",
          "locator": "results[0].application_number, sponsor_name and submissions[16] (ORIG 1)",
          "applicability_note": "openFDA drugsfda JSON, CC0.",
          "snapshot": {
            "id": "maternal:openfda-drugsfda-bla020744-2026-10-15",
            "retrieved_at": "2026-10-15T13:50:49Z",
            "content_hash": "24fdf55079b1b7530db37698f5c3f3bbf75be8173323f8383ffa610016dfa168",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:fda-bla020744",
            "source_type": "regulator",
            "title": "FDA application BLA020744, CUROSURF: openFDA Drugs@FDA record",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020744",
            "identifiers": [
              {
                "scheme": "fda-bla",
                "value": "BLA020744",
                "normalized_value": "BLA020744",
                "match": "exact",
                "version": null,
                "label": null,
                "from_source": false
              }
            ],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration (openFDA)",
            "edition": "The openFDA drugsfda JSON record fetched on 2026-10-15. It gives the application number, sponsor, products, marketing status and the submission history with status dates written YYYYMMDD.",
            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-drugsfda-BLA020744.json.",
            "public_text": "quote",
            "replaced_by": null,
            "retirement_note": null
          }
        },
        {
          "evidence_role": "supports",
          "locator": "results[0].indications_and_usage[0], version and effective_time",
          "applicability_note": "openFDA label record, CC0; label version 45.",
          "snapshot": {
            "id": "maternal:openfda-label-bla020744-2026-10-15",
            "retrieved_at": "2026-10-15T13:51:06Z",
            "content_hash": "d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-label-bla020744",
            "source_type": "regulator",
            "title": "Curosurf prescribing information for BLA020744: openFDA drug label record",
            "canonical_url": "https://api.fda.gov/drug/label.json?search=openfda.application_number:%22BLA020744%22",
            "identifiers": [],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration (openFDA)",
            "edition": "The openFDA drug label endpoint, fetched on 2026-10-15. The wording is the dataset's copy of the label as of the date fetched, not the current DailyMed label.",
            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-label-BLA020744.json. Short quotations only.",
            "public_text": "quote",
            "replaced_by": null,
            "retirement_note": null
          }
        }
      ],
      "review": {
        "content_digest": "a382f9d64529221cb5dd335cd2c3923166f668f47030a6f347e5e0f96f20e82f",
        "current": [],
        "conflicting": [],
        "stale": [],
        "inactive": []
      },
      "api_path": "api/v1/claims/maternal--claim-fda-nda020744-curosurf.json"
    }
  ],
  "decisions": [
    {
      "type": "regulatory_decision",
      "id": "maternal:regdec-fda-nda020744",
      "product_id": "maternal:curosurf",
      "product_version": "Curosurf intratracheal suspension, original approval of NDA 20-744 (openFDA now lists the application as BLA020744, ORIG-1); labelling read is openFDA label version 45, effective 2025-12-10",
      "indication": "The 1999 approval letter words the use as treatment (rescue) of respiratory distress syndrome (RDS) in premature infants; the current US label words it as: indicated for the rescue treatment of respiratory distress syndrome (RDS) in premature infants.",
      "context_id": "maternal:ctx-fda-bla020744-us",
      "jurisdictions": [
        "US"
      ],
      "jurisdiction_note": "United States",
      "authority_id": "core:fda",
      "decision_type": "approval",
      "recall_class": null,
      "submission_id": "NDA020744",
      "pathway": "nda",
      "product_code": null,
      "device_class": null,
      "decision_date": "1999-11-18",
      "valid_to": null,
      "claim_id": "maternal:claim-fda-nda020744-curosurf"
    }
  ],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "contains",
        "label": "Active ingredient (generic name on the label)",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:poractant-alfa",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:openfda-label-bla020744-2026-10-15",
          "locator": "results[0].openfda.generic_name[0]"
        },
        "primary": false,
        "role": "active",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "treats",
        "label": "US label: rescue treatment of RDS in premature infants",
        "clinical_claim_not_fact": true,
        "family": "clinical",
        "other_entity_id": "maternal:neonatal-respiratory-distress-syndrome",
        "other_entity_in_atlas": true,
        "claim_id": "maternal:claim-curosurf-label-rds-effect",
        "evidence": null,
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "part_of",
        "label": "Filed under this front",
        "clinical_claim_not_fact": false,
        "family": "navigation",
        "other_entity_id": "maternal:front-medicines-and-vaccines",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": null,
        "primary": true,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "products/curosurf/",
  "context_path": "api/v1/context/maternal--curosurf.md"
}