MedPath

Perampanel

Generic Name
Perampanel
Brand Names
Fycompa
Drug Type
Small Molecule
Chemical Formula
C23H15N3O
CAS Number
380917-97-5
Unique Ingredient Identifier
H821664NPK

Overview

Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.

Background

Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.

Indication

Perampanel is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in epileptic patients four years of age and older. It is also indicated as an adjunct in the treatment of primary generalized tonic-clonic seizures in epileptic patients aged 12 years and older.

Associated Conditions

  • Epilepsy, Primary Generalized Tonic-Clonic Seizures
  • Partial-Onset Seizures

FDA Approved Products

Fycompa
Manufacturer:Catalyst Pharmaceuticals, Inc.
Route:ORAL
Strength:4 mg in 1 1
Approved: 2024/01/05
NDC:69616-274
Fycompa
Manufacturer:Catalyst Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/01/05
NDC:69616-280
Fycompa
Manufacturer:Eisai Inc.
Route:ORAL
Strength:12 mg in 1 1
Approved: 2023/11/21
NDC:62856-282
Fycompa
Manufacturer:Catalyst Pharmaceuticals, Inc.
Route:ORAL
Strength:0.5 mg in 1 mL
Approved: 2024/01/05
NDC:69616-290
Fycompa
Manufacturer:Eisai Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/11/21
NDC:62856-280

Singapore Approved Products

FYCOMPA FILM-COATED TABLET 2 MG
Manufacturer:Eisai Manufacturing Ltd.
Form:TABLET, FILM COATED
Strength:2.0 mg
Online:Yes
Approved: 2014/09/12
Approval:SIN14616P
FYCOMPA FILM-COATED TABLET 4MG
Manufacturer:Eisai Manufacturing Ltd.
Form:TABLET, FILM COATED
Strength:4.0 mg
Online:Yes
Approved: 2014/09/12
Approval:SIN14617P
FYCOMPA FILM-COATED TABLET 8MG
Manufacturer:Eisai Manufacturing Ltd.
Form:TABLET, FILM COATED
Strength:8.0 mg
Online:Yes
Approved: 2014/09/12
Approval:SIN14619P
FYCOMPA ORAL SUSPENSION 0.5MG/ML
Manufacturer:Delpharm Huningue S.A.S.
Form:SUSPENSION
Strength:0.50 mg/ml
Online:Yes
Approved: 2022/06/10
Approval:SIN16512P

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