perampanel

FDA Drug Profile — Fycompa

Drug Details

Generic Name
perampanel
Brand Names
Fycompa
Application Number
NDA202834
Sponsor
Eisai Manufacturing Ltd
NDC Codes
26
Dosage Forms
TABLET, SUSPENSION
Routes
ORAL
Active Ingredients
PERAMPANEL

Indications and Usage

1 INDICATIONS AND USAGE Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, are indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Perampanel tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.