🇺🇸 Plegridy in United States

FDA authorised Plegridy on 15 August 2014 · 7,573 US adverse-event reports

Marketing authorisations

FDA — authorised 15 August 2014

  • Application: BLA125499
  • Marketing authorisation holder: BIOGEN IDEC INC
  • 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. Influenza Like Illness — 1,450 reports (19.15%)
  2. Injection Site Erythema — 1,051 reports (13.88%)
  3. Multiple Sclerosis Relapse — 950 reports (12.54%)
  4. Fatigue — 703 reports (9.28%)
  5. Headache — 604 reports (7.98%)
  6. Pain — 599 reports (7.91%)
  7. Injection Site Reaction — 576 reports (7.61%)
  8. Device Malfunction — 571 reports (7.54%)
  9. Multiple Sclerosis — 555 reports (7.33%)
  10. Pyrexia — 514 reports (6.79%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Plegridy approved in United States?

Yes. FDA authorised it on 15 August 2014; FDA has authorised it.

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

BIOGEN IDEC INC holds the US marketing authorisation.