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GSK Lamictal Bipolar Claim "Approvable"; Exact Indication Under Discussion

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline is discussing the scope of a bipolar indication for Lamictal following an April 4 "approvable" letter for the new claim.

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FDA approves GSK's Lamictal (lamotrigine) June 20 for long-term maintenance of bipolar I disorder to delay mood episodes (depression, mania, hypomania or mixed episodes) in patients treated for acute mood episodes with standard therapy. The company noted that Lamictal is the first FDA-approved therapy for bipolar maintenance since the gold-standard lithium. Approval was based on two 18-month studies in patients who were currently/recently manic or depressed; combined analysis showed a statistically significant delay to depression and mania over placebo, "although the finding was more robust for depression," GSK said. The scope of the bipolar indication was among the areas under discussion following FDA's April 4 "approvable" letter for the drug (1Pharmaceutical Approvals Monthly May 1, 2003, p. 3). Lamictal is not indicated for the treatment of acute mood episode

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