Fycompa Approval History

  • FDA approved: Yes (First approved October 22nd, 2012)
  • Brand name: Fycompa
  • Generic name: perampanel
  • Company: Eisai Inc.
  • Treatment for: Epilepsy, Seizures

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.

FDA Approval History for Fycompa

DateArticle
Oct 22, 2012Approval FDA Approves Fycompa to Treat Seizures
Mar  5, 2012FDA Accepts Resubmission of Perampanel New Drug Application
Dec 26, 2011Eisai Resubmits Perampanel (E2007) NDA to FDA
Jul 29, 2011U.S. FDA Provides Response to Perampanel New Drug Application
Jan 25, 2011Eisai to Submit Marketing Authorization Applications in the U.S. and EU for Perampanel as Adjunctive Therapy for Partial Onset SeizuresĀ in Patients with Epilepsy

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