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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560280FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

perampanel 12 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560282FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

perampanel 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560272FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

perampanel 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560274FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

perampanel 6 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560276FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

perampanel 8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560278FYCOMPANDAEisai Inc.2012-10-22PERAMPANELORALTABLETNDA20283471cf3309-e182-473c-8b0b-280cabd0e122

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202834FYCOMPAEISAI INC2012-10-22p8772497
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)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202834_001RXPERAMPANEL (2MG)ORALTABLETFalse2012-10-22FYCOMPA
2NDA202834_002RXPERAMPANEL (4MG)ORALTABLETFalse2012-10-22FYCOMPA
3NDA202834_003RXPERAMPANEL (6MG)ORALTABLETFalse2012-10-22FYCOMPA
4NDA202834_004RXPERAMPANEL (8MG)ORALTABLETFalse2012-10-22FYCOMPA
5NDA202834_005RXPERAMPANEL (10MG)ORALTABLETFalse2012-10-22FYCOMPA
6NDA202834_006RXPERAMPANEL (12MG)ORALTABLETTrue2012-10-22FYCOMPA

patent(s)

#idexpiration dateapplication(s)
1p6949571 (view patent)2021-06-08NDA202834
2p8772497 (view patent)2026-05-16NDA202834

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
171cf3309-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 12prescriptionHuman PrescriptionEisai Inc.2015-06-2625628560272, 628560274, 628560276, 628560278, 628560280, 628560282, 628560270

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