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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eisai, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  anticonvulsant
 
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