🇺🇸 Ameluz in United States

FDA authorised Ameluz on 10 May 2016 · 249 US adverse-event reports

Marketing authorisations

FDA — authorised 10 May 2016

  • Application: NDA208081
  • Marketing authorisation holder: BIOFRONTERA
  • 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. Off Label Use — 68 reports (27.31%)
  2. Application Site Pain — 52 reports (20.88%)
  3. Application Site Erythema — 48 reports (19.28%)
  4. Drug Ineffective — 17 reports (6.83%)
  5. Application Site Swelling — 15 reports (6.02%)
  6. Application Site Pustules — 10 reports (4.02%)
  7. Erythema — 10 reports (4.02%)
  8. Hypersensitivity — 10 reports (4.02%)
  9. Pain — 10 reports (4.02%)
  10. Product Colour Issue — 9 reports (3.61%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ameluz approved in United States?

Yes. FDA authorised it on 10 May 2016; FDA has authorised it.

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

BIOFRONTERA holds the US marketing authorisation.