🇺🇸 LEVETIRACETAM in United States

FDA authorised LEVETIRACETAM on 15 January 2009 · 41,690 US adverse-event reports

Marketing authorisations

FDA — authorised 15 January 2009

  • Application: ANDA078976
  • Marketing authorisation holder: ACTAVIS MID ATLANTIC
  • Status: supplemented

FDA — authorised 15 January 2009

  • Application: ANDA078993
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: supplemented

FDA — authorised 10 February 2009

  • Application: ANDA078106
  • Marketing authorisation holder: PRINSTON INC
  • Status: supplemented

FDA — authorised 13 October 2011

  • Application: ANDA090981
  • Marketing authorisation holder: HIKMA FARMACEUTICA
  • Status: supplemented

FDA — authorised 26 June 2013

  • Application: ANDA091627
  • Marketing authorisation holder: SAGENT PHARMS
  • 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 — 8,943 reports (21.45%)
  2. Seizure — 8,882 reports (21.3%)
  3. Off Label Use — 6,154 reports (14.76%)
  4. Maternal Exposure During Pregnancy — 3,021 reports (7.25%)
  5. Epilepsy — 2,822 reports (6.77%)
  6. Drug Interaction — 2,508 reports (6.02%)
  7. Fatigue — 2,507 reports (6.01%)
  8. Foetal Exposure During Pregnancy — 2,502 reports (6%)
  9. Condition Aggravated — 2,284 reports (5.48%)
  10. Status Epilepticus — 2,067 reports (4.96%)

Source database →

LEVETIRACETAM in other countries

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

Frequently asked questions

Is LEVETIRACETAM approved in United States?

Yes. FDA authorised it on 15 January 2009; FDA authorised it on 15 January 2009; FDA authorised it on 10 February 2009.

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

ACTAVIS MID ATLANTIC holds the US marketing authorisation.