🇺🇸 Firmagon in United States

FDA authorised Firmagon on 24 December 2008 · 1,946 US adverse-event reports

Marketing authorisations

FDA — authorised 24 December 2008

  • Application: NDA022201
  • Marketing authorisation holder: FERRING
  • 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. Injection Site Pain — 299 reports (15.36%)
  2. Fatigue — 272 reports (13.98%)
  3. Injection Site Erythema — 248 reports (12.74%)
  4. Hot Flush — 245 reports (12.59%)
  5. Product Storage Error — 177 reports (9.1%)
  6. Injection Site Swelling — 175 reports (8.99%)
  7. Asthenia — 162 reports (8.32%)
  8. Death — 148 reports (7.61%)
  9. Dizziness — 112 reports (5.76%)
  10. Disease Progression — 108 reports (5.55%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Firmagon approved in United States?

Yes. FDA authorised it on 24 December 2008; FDA has authorised it.

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

FERRING holds the US marketing authorisation.