perampanel Oral Tablet

Brand(s): FYCOMPA
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Eisai Inc. (2015-06-26)
Oldest Current Product: 2012-10-22
License(s): NDA

RxNORM: ORAL TABLET\PERAMPANEL
FDAOB: ORAL\TABLET\PERAMPANEL
SPL Active: ORAL\TABLET\PERAMPANEL
SPL Moiety: ORAL\TABLET\PERAMPANEL

product(s) by strength(s)

perampanel 10 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560280	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

perampanel 12 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560282	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

perampanel 2 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560272	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

perampanel 4 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560274	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

perampanel 6 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560276	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

perampanel 8 mg oral tablet

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	628560278	FYCOMPA	NDA	Eisai Inc.	2012-10-22	PERAMPANEL	ORAL	TABLET	NDA202834	71cf3309-e182-473c-8b0b-280cabd0e122

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug
1	NDA202834	FYCOMPA	EISAI INC	2012-10-22	p8772497 p6949571, TREATMENT OF EPILEPSY, SUBSTANCE	NEW CHEMICAL ENTITY [2017-10-22] ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC - CLONIC (PG TC) SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER. [2018-06-19]	NDA202834_001, NDA202834_002, NDA202834_003, NDA202834_004, NDA202834_005, NDA202834_006

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA202834_001	RX	PERAMPANEL (2MG)	ORAL	TABLET	False	2012-10-22	FYCOMPA
2	NDA202834_002	RX	PERAMPANEL (4MG)	ORAL	TABLET	False	2012-10-22	FYCOMPA
3	NDA202834_003	RX	PERAMPANEL (6MG)	ORAL	TABLET	False	2012-10-22	FYCOMPA
4	NDA202834_004	RX	PERAMPANEL (8MG)	ORAL	TABLET	False	2012-10-22	FYCOMPA
5	NDA202834_005	RX	PERAMPANEL (10MG)	ORAL	TABLET	False	2012-10-22	FYCOMPA
6	NDA202834_006	RX	PERAMPANEL (12MG)	ORAL	TABLET	True	2012-10-22	FYCOMPA

patent(s)

#	id	expiration date	application(s)
1	p6949571 (view patent)	2021-06-08	NDA202834
2	p8772497 (view patent)	2026-05-16	NDA202834

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	71cf3309-e182-473c-8b0b-280cabd0e122 (view SPL)	These highlights do not include all the information needed to use FYCOMPA safely and effectively. See full prescribing information for FYCOMPA . FYCOMPA (perampanel) t ablets , for oral use , CIII Initial U.S. Approval: 20 12	prescription	Human Prescription	Eisai Inc.	2015-06-26	25	628560272, 628560274, 628560276, 628560278, 628560280, 628560282, 628560270

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII