🇺🇸 Gilenya in United States

FDA authorised Gilenya on 21 September 2010 · 53,256 US adverse-event reports

Marketing authorisations

FDA — authorised 21 September 2010

  • Application: NDA022527
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: GILENYA
  • Indication: CAPSULE — ORAL
  • Status: approved

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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. Fatigue — 11,081 reports (20.81%)
  2. Headache — 7,345 reports (13.79%)
  3. Multiple Sclerosis Relapse — 7,345 reports (13.79%)
  4. Dizziness — 5,447 reports (10.23%)
  5. White Blood Cell Count Decreased — 4,015 reports (7.54%)
  6. Gait Disturbance — 3,814 reports (7.16%)
  7. Hypoaesthesia — 3,776 reports (7.09%)
  8. Nausea — 3,518 reports (6.61%)
  9. Fall — 3,468 reports (6.51%)
  10. Lymphocyte Count Decreased — 3,447 reports (6.47%)

Source database →

Gilenya in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Gilenya approved in United States?

Yes. FDA authorised it on 21 September 2010; FDA has authorised it.

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

NOVARTIS holds the US marketing authorisation.