Neonatal Respiratory Distress Syndrome

• FDA approval · 2024-08-23
  FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)

  FDA approved a supplemental application for INFASURF (calfactant) from ONY Biotech Inc.

• FDA approval · 2022-07-15
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) from AbbVie Inc.

• FDA approval · 2021-05-17
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Curosurf (poractant alfa) filed by Chiesi USA, Inc. Curosurf is a lung surfactant used to tr…

• FDA approval · 2020-10-26
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc., approving changes to the product's labeling and/o…

• FDA approval · 2019-12-16
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for CUROSURF (poractant alfa) from Chiesi USA, Inc., resulting in updated labeling for the product.

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• FDA approval · 2019-12-16
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) from AbbVie Inc. to update the product’s approval details.

• FDA approval · 2016-11-03
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc.

• FDA approval · 2016-11-01
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc., pertaining to the existing product …

• FDA approval · 2016-02-25
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) from AbbVie Inc.

• FDA approval · 2014-12-03
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc.

• FDA approval · 2014-10-10
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Curosurf (poractant alfa) from Chiesi USA, Inc., updating the product labeling as part of a …

• FDA approval · 2014-03-11
  FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)

  The FDA approved a supplemental application for INFASURF (calfactant) submitted by ONY Biotech Inc., approving labeling changes and/or expan…

• FDA approval · 2014-02-12
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc. This action represents a supplementa…

• FDA approval · 2013-10-18
  FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)

  The FDA approved a supplemental application for INFASURF (calfactant) from ONY Biotech Inc., updating the product labeling. Calfactant is us…

• FDA approval · 2013-06-12
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) by AbbVie.

• FDA approval · 2013-04-15
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for Curosurf (poractant alfa) held by Chiesi USA, Inc.

• FDA approval · 2013-04-10
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc., updating the regulatory status of the product…

• FDA approval · 2011-07-01
  FDA Approved: INFASURF — Supplemental Application (ONY Biotech Inc.)

  The FDA approved a supplemental application for INFASURF (calfactant) from ONY Biotech.

• FDA approval · 2009-01-12
  FDA Approved: SURVANTA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SURVANTA (beractant) submitted by AbbVie Inc. Beractant is used to treat neonatal respirator…

• FDA approval · 2008-09-26
  FDA Approved: CUROSURF — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for Curosurf (poractant alfa) submitted by Chiesi USA, Inc.