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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:  05/29/2009
 
Trade Name:  Lamictal XR
 
Generic Name or Proper Name (*):  lamotrigine
 
Indications Studied:  Adjunctive therapy for partial onset seizures in patients e13 years of age
 
Label Changes Summary:  * Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years * Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established * Information on adverse event profile, and clinical studies * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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