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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Eisai Inc.
Pediatric Exclusivity Granted Date:
01/13/2015
Therapeutic Category:
Anticonvulsant
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