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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:  06/19/2015
 
Trade Name:  Fycompa
 
Generic Name or Proper Name (*):  perampanel
 
Indications Studied:  Treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older
 
Label Changes Summary:  * Safety and efficacy in pediatric patients 12 years and older was established in a randomized double-blind, placebo-controlled, multicenter trial, which included 11 pediatric patients 12 to 16 years exposed to Fycompa; an additional 6 patients were treated with Fycompa in the open label extension of the study * Safety and effectiveness in pediatric patients less than 12 years of age have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, PK, clinical studies, and adverse reactions * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eisai Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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