🇺🇸 NexoBrid in United States

FDA authorised NexoBrid on 28 December 2022 · 26 US adverse-event reports

Marketing authorisation

FDA — authorised 28 December 2022

  • Application: BLA761192
  • Marketing authorisation holder: MEDIWOUND, LTD
  • Local brand name: NEXOBRID
  • Indication: GEL — TOPICAL
  • Status: approved

Read official source →

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. Inappropriate Schedule Of Product Administration — 6 reports (23.08%)
  2. Cardiac Arrest — 4 reports (15.38%)
  3. Lactic Acidosis — 4 reports (15.38%)
  4. Arrhythmia — 3 reports (11.54%)
  5. Atrioventricular Block — 2 reports (7.69%)
  6. Hyperlactacidaemia — 2 reports (7.69%)
  7. Multiple Organ Dysfunction Syndrome — 2 reports (7.69%)
  8. Acute Kidney Injury — 1 report (3.85%)
  9. Atrial Fibrillation — 1 report (3.85%)
  10. Atrioventricular Block Complete — 1 report (3.85%)

Source database →

NexoBrid in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is NexoBrid approved in United States?

Yes. FDA authorised it on 28 December 2022.

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

MEDIWOUND, LTD holds the US marketing authorisation.