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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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