Curosurf (poractant alfa)

Context 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

Premature infants

Gestational age

Not reported

Postnatal age

Not reported

Follow-up

Not applicable (regulatory context)

• Effect Guidance Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • Not stated in the source (the indication text does not name a setting)
  • United States (FDA-approved labelling)
  • Premature infants
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-15

  Next evidence check due

  Not scheduled

  Sources and citations (1)

  1. Supports Curosurf prescribing information for BLA020744: openFDA drug label record

     Regulator · 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.

     Locator

     results[0].indications_and_usage[0]

     How it applies

     openFDA label record, CC0.

     Retrieved

     2026-10-15T13:51:06Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae

     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.

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • Not stated in the source (the indication text does not name a setting)
  • United States (FDA-approved labelling)
  • Premature infants
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-15

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA approval letter, NDA 20-744, Curosurf (poractant alfa) Intratracheal Suspension (1999)

     Regulator · 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.

     Locator

     Page 1: header, paragraphs 1 and 4

     How it applies

     1999 approval letter for NDA 20-744; short quotation; scanned image typed by hand.

     Retrieved

     2026-10-15T14:45:39Z

     Source effective date

     1999-11-18

     Source state

     Current

     Snapshot hash

     2f27c0a9299bd0776779a3bcd310724ecd2475065641b97f6dd19b653c63801d

     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.

  2. Supports FDA application BLA020744, CUROSURF: openFDA Drugs@FDA record

     Regulator · 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. · BLA: BLA020744

     Locator

     results[0].application_number, sponsor_name and submissions[16] (ORIG 1)

     How it applies

     openFDA drugsfda JSON, CC0.

     Retrieved

     2026-10-15T13:50:49Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     24fdf55079b1b7530db37698f5c3f3bbf75be8173323f8383ffa610016dfa168

     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.

  3. Supports Curosurf prescribing information for BLA020744: openFDA drug label record

     Regulator · 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.

     Locator

     results[0].indications_and_usage[0], version and effective_time

     How it applies

     openFDA label record, CC0; label version 45.

     Retrieved

     2026-10-15T13:51:06Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae

     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.