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Biovail receives approval for Wellbutrin XL depression drug in Canada
By Angela McDaniels
Seattle, Jan. 17 - Biovail Corp. said the Therapeutic Products Directorate Canada has issued a Notice of Compliance for 150 mg and 300 mg tablet strengths of Wellbutrin XL, a once-daily, extended-release formulation of bupropion hydrochloride for the treatment of depression.
Biovail Pharmaceuticals Canada, Biovail's Canadian sales and marketing division, will launch Wellbutrin XL late in the first quarter of 2006.
"Once-daily Wellbutrin XL is an effective first-line treatment for depression with a low incidence of sexual dysfunction, weight gain and somnolence," Biovail Pharmaceuticals Canada vice president and general manager Douglas Herman said in a company release.
"This tolerability profile is important, given that drug-related side effects of anti-depressants are a major reason why treatment may be discontinued."
The drug has a dual mode of action on norepinephrine and dopamine and, unlike other treatments for depression, does not affect serotonin. Wellbutrin XL will be the first and only once-daily formulation of bupropion available in Canada, according to the release.
Biovail developed the formulation for Wellbutrin XL and in October 2001, entered into a distribution and supply agreement with GlaxoSmithKline for the United States and the rest of the world, excluding Canada. GlaxoSmithKline launched the drug in the United States in September 2003.
Biovail estimated the Canadian depression market at C$760 million.
Biovail is a specialty pharmaceutical company based in Toronto that formulizes, manufactures and commercializes pharmaceutical products using advanced drug-delivery technologies.
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