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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:  02/12/2015
 
Trade Name:  Banzel
 
Generic Name or Proper Name (*):  rufinamide
 
Indications Studied:  Adjunctive treatment of seizures associated with Lennox Gastaut Syndrome
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients down to 1 year; Previously approved in 4 years and older. *The effectiveness in patients in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study *Safety and effectiveness in pediatric patients below the age of 1 year has not been established *Adverse reactions were similar to those observed in adults and pediatric patients 4 years and older *Information on clinical trial, dosing and adverse reactions in 1 to less than 4 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Eisai Inc.
 
Pediatric Exclusivity Granted Date:  01/13/2015
 
Therapeutic Category:  Anticonvulsant
 
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