GSK Lamictal for bipolar I
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline is seeking Lamictal (lamotrigine) indication for long-term management of bipolar I disorder to delay the relapse/recurrence of depressive episodes. The sNDA, submitted Aug. 29, includes two 18-month, double-blind, placebo-controlled studies in 638 patient