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Wellbutrin XL Approved by FDA

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London, UK, August 28, 2003 – GlaxoSmithKline announced today that Wellbutrin XL (bupropion hydrochloride extended-release tablets) has been approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder in patients 18 years and older. Wellbutrin XL is the first once-daily norepinephrine and dopamine reuptake inhibitor (NDRI) for the treatment of depression. GlaxoSmithKline expects Wellbutrin XL to be available in pharmacies by mid-September.

Depressive illness affects approximately 14 million adults or 6.6 percent of the US population in a given year. In the US there is more than a 16 per cent chance for an adult to develop major depressive disorder in his or her lifetime. Nearly two-thirds of people fail to get help for their depression, yet treatment can alleviate symptoms in more than 80 per cent of cases.

"Wellbutrin XL builds on a strong foundation. Through the first half of 2003, our twice-daily formulation, Wellbutrin SR , has remained the number one prescribed antidepressant among US psychiatrists," said Chris Viehbacher, President, US Pharmaceuticals. "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."

Wellbutrin XL tablets have a two-layered coating designed to release drug slowly in the body. GlaxoSmithKline licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001.

Source: GlaxoSmithKline press release 2003.

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