🇺🇸 Keppra in United States

FDA authorised Keppra on 30 November 1999 · 30,584 US adverse-event reports

Marketing authorisations

FDA — authorised 30 November 1999

  • Application: NDA021035
  • Marketing authorisation holder: UCB INC
  • Status: supplemented

FDA — authorised 15 July 2003

  • Application: NDA021505
  • Marketing authorisation holder: UCB INC
  • Status: supplemented

FDA — authorised 31 July 2006

  • Application: NDA021872
  • Marketing authorisation holder: UCB INC
  • Status: approved

FDA — authorised 12 September 2008

  • Application: NDA022285
  • Marketing authorisation holder: UCB 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. Seizure — 7,291 reports (23.84%)
  2. Off Label Use — 3,383 reports (11.06%)
  3. Drug Ineffective — 3,357 reports (10.98%)
  4. Fatigue — 3,209 reports (10.49%)
  5. Convulsion — 2,950 reports (9.65%)
  6. Somnolence — 2,209 reports (7.22%)
  7. Headache — 2,143 reports (7.01%)
  8. Nausea — 2,091 reports (6.84%)
  9. Fall — 2,010 reports (6.57%)
  10. Dizziness — 1,941 reports (6.35%)

Source database →

Keppra 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 Keppra approved in United States?

Yes. FDA authorised it on 30 November 1999; FDA authorised it on 15 July 2003; FDA authorised it on 31 July 2006.

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

UCB INC holds the US marketing authorisation.