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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:  12/16/2011
 
Trade Name:  Keppra
 
Generic Name or Proper Name (*):  levetiracetam
 
Indications Studied:  Adjunctive therapy in the treatment of partial onset seizures
 
Label Changes Summary:  * Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and older* In pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patients* Information on dosing, clinical trial, adverse reactions
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  UCB
 
Pediatric Exclusivity Granted Date:  06/03/2008
 
NNPS:  TRUE
 
Therapeutic Category:  Anticonvulsant
 
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