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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:  01/29/2010
Trade Name:  Lamictal XR
Generic Name or Proper Name (*):  lamotrigine
Indications Studied:  Adjunctive therapy for Primary Generalized Tonic-Clonic seizures
Label Changes Summary:  * New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age * Safety and effectiveness for any use in patients < 13 years have not been established * Information on dosing, adverse reactions, and clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  GlaxoSmithKline
Therapeutic Category:  Anticonvulsant