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
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