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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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