🇺🇸 fampridine in United States

FDA authorised fampridine on 22 January 2010 · 577 US adverse-event reports

Marketing authorisations

FDA — authorised 22 January 2010

  • Application: NDA022250
  • Marketing authorisation holder: MERZ
  • Local brand name: AMPYRA
  • Indication: TABLET, EXTENDED RELEASE — 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 — 82 reports (14.21%)
  2. Fall — 69 reports (11.96%)
  3. Gait Disturbance — 69 reports (11.96%)
  4. Asthenia — 63 reports (10.92%)
  5. Multiple Sclerosis Relapse — 55 reports (9.53%)
  6. Dizziness — 51 reports (8.84%)
  7. Headache — 48 reports (8.32%)
  8. Urinary Tract Infection — 48 reports (8.32%)
  9. Nausea — 47 reports (8.15%)
  10. Hypoaesthesia — 45 reports (7.8%)

Source database →

fampridine 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 fampridine approved in United States?

Yes. FDA authorised it on 22 January 2010; FDA has authorised it.

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

MERZ holds the US marketing authorisation.