GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the new drug application (NDA) for Lamictal®XR™ (lamotrigine) Extended-Release Tablets.
This decision does not affect the current formulation of Lamictal® (lamotrigine) Tablets, which remains an important treatment for many patients with epilepsy.
Lamictal XR is an investigational once-daily extended-release formulation. The current marketed immediate-release formulation of Lamictal is twice daily for most patients with epilepsy. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.