Prescription medicine
Poractant alfa Brand names: Curosurf
Poractant alfa (Curosurf) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the poractant alfa FDA label on DailyMed (effective December 10, 2025, Chiesi USA, Inc.); the BLA 20744 record on Drugs@FDA; every poractant alfa label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants.
Forms and strengths
- 80 mg/ml
Suspension.
On the market
- Earliest approval on file
- November 18, 1999 Curosurf, Chiesi Usa Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest March 17, 2026
- FAERS reports
- 714 through July 30, 2026
What is poractant alfa used for?
From the label: indications and usageCUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.
FDA pharmacologic class: Surfactant.
Source: FDA drug label (Curosurf), Chiesi USA, Inc., effective December 10, 2025 (SPL set 99bef307-00bd-4379-9f45-ede1380e74d4), via openFDA; the full label on DailyMed
Is there a generic for poractant alfa (Curosurf)?
No generic poractant alfa is approved (Drugs@FDA, October 8, 2026).
- 1999 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has poractant alfa been recalled?
The FDA's Enforcement Report lists 1 recall naming poractant alfa since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 17, 2026 | Class II | Chiesi USA, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for poractant alfa?
The FDA Adverse Event Reporting System holds 714 reports that list poractant alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 216 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other surfactants
- the pharmacologic class, with prices and generics
- Poractant alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other