Biovail gets Canadian approval for anti-depression drug
CBC || January 18, 2006
Biovail Corp. has won approval to market Wellbutrin XL, a drug treatment for depression in adults, the pharmaceutical company said Tuesday.
The Toronto company (TSX:BVF) said Health Canada's Therapeutic Products Directorate gave the nod to the 150 mg and 300 mg tablet strengths of the once-a-day drug.
Biovail aims to begin selling the drug late in the first quarter of this year.
The company said the market for anti-depressants in Canada is worth about $760 million.
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"Once-daily Wellbutrin XL is an effective first-line treatment for depression with a low incidence of sexual dysfunction, weight gain and somnolence," said Douglas Herman, vice-president and general manager of Biovail Pharmaceuticals Canada.
"This tolerability profile is important, given that drug-related side-effects of anti-depressants are a major reason why treatment may be discontinued."
However, side-effects in clinical trials included headaches, insomnia, dizziness and decreased appetite, the company cautioned.
Developed by Biovail in October 2001, the drug has been on the market in the United States since September 2003. Biovail said an estimated 1.4 million Canadians are affected by depression.
Shares of Biovail traded down 28 cents at $30.27 in afternoon activity on the TSX.
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