Fycompa

Treats partial-onset seizures with or without secondarily generalized seizures. NDA 202834, held by Catalyst Pharms. Perampanel.

As of Nov 13, 2026, NDA 202834 (Fycompa), held by Catalyst Pharms, was first approved by FDA on Oct 22, 2012, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2012
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial - Onset Seizures FYCOMPA is 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Sep 27, 2018	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide Letter Pediatric CDTL Review
Jul 26, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide Pediatric Medical Review
Jun 19, 2015	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Statistical Review Pediatric Medical Review
Oct 22, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Clinical Pharmacology Review

Products

6 strengths and forms


Fycompa2MG · tablet;oral	Perampanel	RxReference drug
Fycompa4MG · tablet;oral	Perampanel	RxReference drug
Fycompa6MG · tablet;oral	Perampanel	RxReference drug
Fycompa8MG · tablet;oral	Perampanel	RxReference drug
Fycompa10MG · tablet;oral	Perampanel	RxReference drug
Fycompa12MG · tablet;oral	Perampanel	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Dec 5, 2023	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 26, 2023	Supplement 18Labeling · Standard review	Approved	Letter Label
May 30, 2019	Supplement 16Labeling · Standard review	Approved	Letter Medication Guide Label
Sep 27, 2018	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide Letter Pediatric CDTL Review
Jul 26, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide Pediatric Medical Review
Nov 3, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label Pediatric Statistical Review
Oct 26, 2016	Supplement 10Manufacturing	Approved	None posted
Dec 23, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 14, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 19, 2015	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Statistical Review Pediatric Medical Review
Nov 14, 2014	Supplement 6Labeling · Standard review	Approved	Label Letter
Feb 24, 2014	Supplement 3Labeling · Standard review	Approved	Letter
Feb 14, 2014	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 2, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 30, 2013	Supplement 1Labeling · Standard review	Approved	Label Letter
Oct 22, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Clinical Pharmacology Review

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: FycompaOct 11, 2018

Identifiers

Application: NDA 202834
Drugs@FDA: Overview at FDA
Company: Catalyst Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters