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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:  10/19/2012
 
Trade Name:  Oxtellar XR
 
Generic Name or Proper Name (*):  oxcarbazepine
 
Indications Studied:  Adjunctive therapy of partial seizures
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients ages 6 - 16 years with partial onset seizures is supported by an adequate and well-controlled short term safety and efficacy study in adults that included pharmacokinetic sampling, a pharmacokinetic study in pediatric patients ages 4 - 16 years, and safety and efficacy studies with the immediate-release formulation in adults and pediatric patients * Oxtellar XR is not approved for pediatric patients < 6 years because the size of the tablets are inappropriate for younger children, and has not been studied in patients < 4 years * Information on dosing, adverse reactions, and pharmacokinetics * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Supernus Pharmaceuticals
 
NNPS:  False
 
Therapeutic Category:  Anticonvulsant
 
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