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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:  12/22/2009
 
Trade Name:  Topamax
 
Generic Name or Proper Name (*):  topiramate
 
Indications Studied:  Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months
 
Label Changes Summary:  * Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures * Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. * Information added to Warnings and Precautions and Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Ortho-McNeil-Janssen
 
Pediatric Exclusivity Granted Date:  07/24/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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