🇺🇸 Infasurf in United States

FDA authorised Infasurf on 1 July 1998 · 127 US adverse-event reports

Marketing authorisations

FDA — authorised 1 July 1998

  • Application: BLA020521
  • Marketing authorisation holder: ONY
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Endotracheal Intubation Complication — 34 reports (26.77%)
  2. Oxygen Saturation Decreased — 21 reports (16.54%)
  3. Neonatal Disorder — 16 reports (12.6%)
  4. Pneumothorax — 13 reports (10.24%)
  5. Pulmonary Haemorrhage — 10 reports (7.87%)
  6. Bradycardia — 8 reports (6.3%)
  7. Cardio-Respiratory Arrest — 7 reports (5.51%)
  8. Heart Rate Decreased — 6 reports (4.72%)
  9. Obstructive Airways Disorder — 6 reports (4.72%)
  10. Pulmonary Interstitial Emphysema Syndrome — 6 reports (4.72%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is Infasurf approved in United States?

Yes. FDA authorised it on 1 July 1998; FDA has authorised it.

Who is the marketing authorisation holder for Infasurf in United States?

ONY holds the US marketing authorisation.