Infasurf Preservative Free

Lowers the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of…. BLA 20521, held by Ony. Calfactant.

As of Nov 14, 2026, BLA 20521 (Infasurf Preservative Free), held by Ony, was first approved by FDA on Jul 1, 1998, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1998
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jul 1, 1998	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Infasurf Preservative Free35MG/ML · suspension;intratracheal	Calfactant	Rx

All 19 submissions, including labeling and manufacturing supplements


Aug 23, 2024	Supplement 38Labeling · Standard review	Approved	Label Letter
Mar 9, 2015	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 11, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 23, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 18, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 1, 2011	Supplement 24Labeling	Approved	Letter Label
Dec 10, 2009	Supplement 21Manufacturing	Approved	None posted
Dec 12, 2002	Supplement 8Manufacturing · Standard review	Approved	Letter
Sep 13, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 18, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 18, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 19, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 20, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
May 18, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 23, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 14, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 17, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 1, 1998	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 20521
Drugs@FDA: Overview at FDA
Company: ONY

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters