🇺🇸 Filsuvez in United States

FDA authorised Filsuvez on 18 December 2023 · 128 US adverse-event reports

Marketing authorisations

FDA — authorised 18 December 2023

  • Application: NDA215064
  • Marketing authorisation holder: CHIESI
  • Status: approved

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. Wound Complication — 29 reports (22.66%)
  2. Wound — 17 reports (13.28%)
  3. Drug Ineffective — 14 reports (10.94%)
  4. Wound Infection — 11 reports (8.59%)
  5. Blister — 10 reports (7.81%)
  6. Ill-Defined Disorder — 10 reports (7.81%)
  7. Wrong Technique In Product Usage Process — 10 reports (7.81%)
  8. Product Dose Omission Issue — 9 reports (7.03%)
  9. Pruritus — 9 reports (7.03%)
  10. Wound Secretion — 9 reports (7.03%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Filsuvez approved in United States?

Yes. FDA authorised it on 18 December 2023; FDA has authorised it.

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

CHIESI holds the US marketing authorisation.