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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:  04/29/2016
 
Trade Name:  Fycompa
 
Generic Name or Proper Name (*):  perampanel
 
Indications Studied:  Adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older
 
Label Changes Summary:  * New Fycompa oral suspension has comparable bioavailability to Fycompa tablets under steady state. Both formulations may be used interchangeably. *Measure oral suspension using provided adaptor and dosing syringe. * Information on administration of oral suspension. *New formulation.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eisai Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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