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