Approval covers Lamictal XR in patients aged 13 years and over.
FDA has approved GlaxoSmithKline’s Lamictal® XR™ (lamotrigine) extended-release tablets for conversion to monotherapy in patients aged 13 years and over, with partial seizures taking one anti-epileptic drug. Lamictal was previously approved as an add-on therapy for partial seizures and primary generalized tonic-clonic seizures in patients in this age group.
Conversion to monotherapy involves adding a new anti-epileptic drug to the patient’s existing drug therapy regimen while gradually reducing the original treatment. Clearance of Lamictal XR for this indication was based on data from the LAM30055 historical control study, carried out as a pooled analysis of previously conducted conversion to monotherapy studies.