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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:  05/18/2015
 
Trade Name:  Lamictal
 
Generic Name or Proper Name (*):  lamotrigine
 
Indications Studied:  Maintenance treatment of bipolar disorder
 
Label Changes Summary:  * Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 *Information on clinical trial and adverse reactions *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant; Mood Stablizer
 
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