← FDA DRUG APPROVALS

FDA NDA · NDA202834

FYCOMPA

perampanel

Sponsor: CATALYST PHARMS

APPLICATION
NDA202834
TYPE
NDA
ORIGINAL APPROVAL
2012-10-22
LATEST ACTION
2023-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FYCOMPA · ReferencePrescription
PERAMPANEL 10MG · TABLET · ORAL
FYCOMPA · ReferencePrescription
PERAMPANEL 6MG · TABLET · ORAL
FYCOMPA · ReferencePrescription
PERAMPANEL 2MG · TABLET · ORAL
FYCOMPA · ReferencePrescription
PERAMPANEL 12MG · TABLET · ORAL
FYCOMPA · ReferencePrescription
PERAMPANEL 8MG · TABLET · ORAL
FYCOMPA · ReferencePrescription
PERAMPANEL 4MG · TABLET · ORAL

Approval history

2023-12-05Labeling · Supplement 19 · standard — Letter ↗AP
2023-10-26Labeling · Supplement 18 · standard — Letter ↗AP
2019-05-30Labeling · Supplement 16 · standard — Medication Guide ↗AP
2018-09-27Efficacy · Supplement 14 · priority — Letter ↗AP
2017-07-26Efficacy · Supplement 12 · standard — Letter ↗AP
2016-11-03Labeling · Supplement 11 · standard — Label ↗AP
2016-10-26Manufacturing (CMC) · Supplement 10 · unknownAP
2015-12-23Manufacturing (CMC) · Supplement 9 · standardAP
2015-12-14Manufacturing (CMC) · Supplement 7 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 8 · standardAP
2015-06-19Efficacy · Supplement 5 · standard — Pediatric Statistical Review ↗AP
2014-11-14Labeling · Supplement 6 · standard — Label ↗AP
2014-02-24Labeling · Supplement 3 · standard — Letter ↗AP
2014-02-14Labeling · Supplement 4 · standard — Letter ↗AP
2013-09-02Manufacturing (CMC) · Supplement 2 · standardAP
2013-06-30Labeling · Supplement 1 · standard — Letter ↗AP
2012-10-22Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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