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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:  09/22/2006
Trade Name:  Lamictal Tablets Lamictal Chewable Dispersible Tablets
Generic Name or Proper Name (*):  lamotrigine
Indications Studied:  Adjunctive therapy for primary generalized tonic-clonic seizures in children 2 years of age and older
Label Changes Summary:  * Effectiveness established in study with patients down to 2 years of age * Revised boxed warning to remove restrictions on use in pediatric patients * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  GlaxoSmithKline
Therapeutic Category:  Anticonvulsant