# Curosurf (poractant alfa)

Product · id `maternal:curosurf` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public)

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Also called: Curosurf; CUROSURF

Browse, life stage: Newborn  
Browse, care area: Preterm and sick newborns  

## In plain language

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.

## Technical summary

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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Effect
- Evidence stage: Guidance
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: Curosurf prescribing information for BLA020744: openFDA drug label record (Regulator, 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.) <https://api.fda.gov/drug/label.json?search=openfda.application_number:%22BLA020744%22>
     Locator: results\[0\].indications\_and\_usage\[0\]. Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae.
     How it applies: openFDA label record, CC0.

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA approval letter, NDA 20-744, Curosurf (poractant alfa) Intratracheal Suspension (1999) (Regulator, 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.) <https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf>
     Locator: Page 1: header, paragraphs 1 and 4. Retrieved 2026-10-15T14:45:39Z. Source state: Current. Snapshot hash: 2f27c0a9299bd0776779a3bcd310724ecd2475065641b97f6dd19b653c63801d.
     How it applies: 1999 approval letter for NDA 20-744; short quotation; scanned image typed by hand.
  2. Supports: FDA application BLA020744, CUROSURF: openFDA Drugs@FDA record (Regulator, 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.) <https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020744>
     Locator: results\[0\].application\_number, sponsor\_name and submissions\[16\] (ORIG 1). Retrieved 2026-10-15T13:50:49Z. Source state: Current. Snapshot hash: 24fdf55079b1b7530db37698f5c3f3bbf75be8173323f8383ffa610016dfa168.
     How it applies: openFDA drugsfda JSON, CC0.
  3. Supports: Curosurf prescribing information for BLA020744: openFDA drug label record (Regulator, 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.) <https://api.fda.gov/drug/label.json?search=openfda.application_number:%22BLA020744%22>
     Locator: results\[0\].indications\_and\_usage\[0\], version and effective\_time. Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: d2bc619215f7cf486e7fdf724222be5e5157e1cea66df1b59ab70afa0d001bae.
     How it applies: openFDA label record, CC0; label version 45.

## Guidance, authorization and access

### Regulatory decision `maternal:regdec-fda-nda020744`

- Product: Curosurf (poractant alfa) (`maternal:curosurf`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 1999-11-18
- 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
- Pathway: NDA
- Submission: NDA020744
- 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.
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `maternal:claim-fda-nda020744-curosurf`

## Connected pages

- Active ingredient (generic name on the label): Poractant alfa (`maternal:poractant-alfa`)
- US label: rescue treatment of RDS in premature infants: Respiratory distress syndrome in preterm babies (`maternal:neonatal-respiratory-distress-syndrome`) [a claim, not a settled fact; see claim `maternal:claim-curosurf-label-rds-effect` and its context]
- Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`)

## Provenance

Content hash: 976d251a9d03ad87b68743f6224c0aadee44f311381430deea017115df9caa45
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15