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Lamictal filed with FDA for indication in depressive episodes.

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| October 14, 2002 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2002 OCT 14 - (NewsRx.com & NewsRx.net) -- GlaxoSmithKline (GSK) announced it is seeking the first-ever indication for long-term management of bipolar I disorder to delay the relapse/recurrence of depressive episodes.

GSK filed a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for Lamictal (lamotrigine).

An estimated 2.3 million American adults have bipolar disorder (also known as manic depression). The depressive phase of bipolar disorder, often referred to as bipolar depression, is a serious condition that puts people at significant risk for suicide and other harmful behaviors. In fact, approximately 1 in 5 people with bipolar disorder attempt suicide, typically during a depressed or mixed (depression and mania) episode.…

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Source: HighBeam Research, Lamictal filed with FDA for indication in depressive episodes.

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