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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:  10/22/2012
 
Trade Name:  Fycompa
 
Generic Name or Proper Name (*):  perampanel
 
Indications Studied:  Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
 
Label Changes Summary:  The safety and efficacy was established by 3 double blind, placebo-controlled studies which included 72 pediatric patients 12 - 16 years old exposed to perampanel The safety and effectiveness in pediatric patients <12 years old have not been established Most common adverse reactions in adult and pediatric patients include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, and balance disorder Information on clinical trials, dosing, adverse reactions, and pharmacokinetics New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eisai Medical Research
 
NNPS:  FALSE'
 
Therapeutic Category:  Anticonvulsant
 
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