Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
09/27/2018
Trade Name:
Fycompa
Generic Name or Proper Name (*):
perampanel
Indications Studied:
Treatment of partial onset seizures (POS), with or without secondarily generalized seizures in patients 4 years and older
Label Changes Summary:
*Expanded the POS indication to include pediatric patients 4 to less than 12 years; previously approved for use in pediatric patients 12 years and older. *Safety and effectiveness for the POS indication have been not been established in pediatric patients less than 4 years. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Eisai, Inc.
NNPS:
FALSE
Therapeutic Category:
anticonvulsant
-
-