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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:  07/26/2017
 
Trade Name:  Fycompa
 
Generic Name or Proper Name (*):  perampanel
 
Indications Studied:  Monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older
 
Label Changes Summary:  *Expanded the indication to include use as monotherapy for the treatment POS in patients with epilepsy aged 12 years and older; previously approved for use as adjunctive therapy. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eisai Inc.
 
Therapeutic Category:  Anticonvulsant
 
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