🇺🇸 Simponi in United States

FDA authorised Simponi on 24 April 2009 · 111,603 US adverse-event reports

Marketing authorisations

FDA — authorised 24 April 2009

  • Application: BLA125289
  • Marketing authorisation holder: CENTOCOR ORTHO BIOTECH INC
  • Status: supplemented

FDA — authorised 18 July 2013

  • Application: BLA125433
  • Marketing authorisation holder: JANSSEN BIOTECH
  • 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. Drug Ineffective — 20,161 reports (18.06%)
  2. Rheumatoid Arthritis — 13,538 reports (12.13%)
  3. Pain — 12,878 reports (11.54%)
  4. Fatigue — 10,727 reports (9.61%)
  5. Off Label Use — 9,459 reports (8.48%)
  6. Joint Swelling — 9,365 reports (8.39%)
  7. Arthralgia — 9,265 reports (8.3%)
  8. Rash — 8,979 reports (8.05%)
  9. Alopecia — 8,783 reports (7.87%)
  10. Drug Intolerance — 8,448 reports (7.57%)

Source database →

Simponi in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Simponi approved in United States?

Yes. FDA authorised it on 24 April 2009; FDA authorised it on 18 July 2013; FDA has authorised it.

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

CENTOCOR ORTHO BIOTECH INC holds the US marketing authorisation.