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Canada Approves Ditropan XL (Oxybutynin Chloride) for Overactive Bladder
TORONTO, ON -- June 11, 2001 -- Alza Corporation today announced that it has received clearance from the Therapeutic Products Directorate (TPD) to market Ditropan® XL (oxybutynin chloride) in Canada.
Ditropan XL will be the first and only once-a-day treatment for the symptoms of overactive bladder in Canada. An estimated 1.5 million Canadians suffer from overactive bladder, with the condition most prevalent among women and older adults.
"The Canadian Continence Foundation encourages all research in the area of urinary incontinence and the development of new medications that may benefit patients living with this condition," said Ruth Pelletier, Executive Director, The Canadian Continence Foundation. "We are pleased to hear of a new treatment option for individuals suffering from overactive bladder."
Ditropan XL is a once-daily controlled-release tablet indicated for the relief of the symptoms of urge incontinence, urgency and frequency, in patients with overactive bladder. Ditropan XL received marketing approval by the U.S. Food and Drug Administration in December 1998 and has gained 25 per cent of the market since then. In June 2000, Sanofi-Synthelabo, Alza’s marketing partner for Ditropan XL in Europe received licenses from the United Kingdom (UK) Medicines Control Agency granting authorization to market the product in the UK, which will serve as the reference member state for mutual recognition procedures in the European Union.
"Ditropan XL is an exciting new product for Canadians who suffer from the symptoms of overactive bladder," said Sid Radomski, M.D., Associate Professor, Department of Surgery, University of Toronto and Deputy Chief of Urology, Toronto Western Hospital.
Ditropan XL treats the symptoms of overactive bladder by combining proven medicine and technology. This new treatment combines conventional oxybutynin - the most commonly prescribed therapy for overactive bladder in Canada - with Alza’s patented Oros® osmotic technology. Two features of this technology are maintaining a more consistent plasma concentration and once-a-day dosing.
At present, overactive bladder is widely under-diagnosed and under-treated. In Canada, less than 50 per cent of patients with overactive bladder discuss this condition with their physician - in part because of embarrassment and the myth that overactive bladder is a normal part of aging. Of those patients seeking treatment, less than 50 per cent use pharmacologic agents to address their symptoms of overactive bladder.
SOURCE: ALZA Corporation
Related Link: ALZA Corporation.
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