GlaxoSmithKline announced that the FDA has approved Lamictal XR (lamotrigine extended-release tablets) for conversion to monotherapy in patients ≥13 years with partial seizures taking one anti-epileptic drug. This approval was based on data from study LAM30055, an international, multicenter, historical control study evaluating Lamictal XR 300mg/day and 250mg/day for conversion to monotherapy in 226 patients ≥13 years with partial seizures taking one anti-epileptic drug.
Lamictal XR is already indicated as add-on treatment for partial seizures and primary generalized tonic-clonic seizures in patients ≥13 years.
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