FDA approves Wellbutrin XL(TM)( idepressant among U.S. psychiatrists ...),Health

idepressant among U.S. psychiatrists," said Chris Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline. "Yet we know that for many doctors twice-daily dosing is a major prescribing barrier. We are confident that the convenient once-daily dosing of Wellbutrin XL will be a welcome improvement for patients coping with depressive illness and for the physicians who are treating them."

HOW WELLBUTRIN XL WORKS

Wellbutrin XL is the first and only once-daily norepinephrine and dopamine reuptake inhibitor (NDRI) for the treatment of depression in adults. The active ingredient in Wellbutrin XL bupropion hydrochloride is believed to act upon norepinephrine and dopamine, two chemicals in the brain known to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals are associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin, a third brain chemical involved in mood regulation.

"In my clinical practice of treating patients with depression, sexual problems and weight change may be related to the depression itself, or these problems may arise as side effects of the antidepressant treatment," said James F. Pradko, M.Sc., M.D. a practicing physician and the director of the Bay Pointe Depression Clinic in Detroit MI. "In either case, sexual function and weight issues relating to depression should be addressed and can have an impact on a patient's treatment and well-being."

CLINICAL HIGHLIGHTS

The approval of Wellbutrin XL was based on bioequivalence to Wellbutrin Tablets (the immediate-release formulation of bupropion). Wellbutrin XL has also been proven bioequivalent to Wellbutrin SR Tablets (the sustained-release formulation of bupropion).

The efficacy of bupropion in the treatment of a major depressive episode was established using the immediate-release formulation in two four-week controlled trials of in
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Contact: Holly Russell
919-483-2839
Cooney Waters Group, Inc.
29-Aug-2003

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