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Fycompa FDA Approval History

FDA Approved: Yes (First approved October 22, 2012)
Brand name: Fycompa
Generic name: perampanel
Dosage form: Tablets and Oral Suspension
Company: Eisai Inc.
Treatment for: Epilepsy, Seizures

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated for the treatment of partial-onset seizures, and as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.

Development timeline for Fycompa

Sep 28, 2018Approval FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
Jul 27, 2017Approval FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-Onset Seizures
May  2, 2016Approval Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
Jun 22, 2015Approval FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures
Oct 22, 2012Approval FDA Approves Fycompa (perampanel) to Treat Partial Onset 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

Further information

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