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news.Labopharm's new drug submission of its once-daily tramadol has been accepted for review by the Therapeutic Products Directorate of Health Canada. The submission is subject to a targeted 300-day review period.
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Labopharm said that it intends to commercialize its once-daily tramadol product in key markets globally and is actively engaged in discussions to establish a marketing partnership for Canada.
Tramadol is currently available in Canada only in an immediate-release (four- to six-times daily) formulation of the product that combines tramadol with acetaminophen. The new once-daily drug has received regulatory approval in 22 European countries and Mexico and commercial launch of the product across Europe is underway.
Canada is the eighth largest pharmaceutical market in the world with sales in 2005 of more than $16.6 billion. Sales of pain medications in Canada in 2005 exceeded $850 million.