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US FDA Approves Lamotrigine XR Tablets for the Treatment of Partial Seizures

April 29, 2011

The United States Food and Drug Administration approved lamotrigine extended-release tablets (Lamictal XR, GlaxoSmthiKline) for the treatment of partial seizures in patients greater than or equal to 13 years of age who are already receiving one anti-eplieptic medication.

Approval was based on results from the LAM30055 study, an international, multicenter, historical control study of 226 patients greater than or equal to 13 years of age. These patients were already receiving one anti-eplieptic, and lamotrigine XR was then added to each patient’s regimen. From there, the original anti-epileptic was gradually withdrawn while lamotrigine XR became monotherapy.

The most common adverse events (those occurring in greater than or equal to 5% of patients) found in either treatment group were dizziness, headache, insomnia, nasopharyngitis, nausea, rash, and somnolence.

For more information on lamotrigine, please consult the medication’s full prescribing information (www.lamictal.com). —Christopher Naccari

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From → FDA Report

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