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UK Approves Ditropan XL (Oxybutynin) For Urinary Incontinence MOUNTAIN VIEW, CA -- June 19, 2000 -- ALZA Corporation announced that Sanofi-Synthelabo, ALZA's marketing partner in Europe for Ditropan® XL (oxybutynin chloride), has received licenses from the UK Medicines Control Agency granting authorization to market three dosage strengths of the product in the United Kingdom which will serve as the reference member state for mutual recognition procedures in the European Union. Sanofi-Synthelabo also is seeking registration for Ditropan XL in non-union European countries outside the European Union. Ditropan XL will be the first once-daily treatment for urinary urge incontinence in Europe. In the United States, Ditropan XL is indicated for the once-a-day treatment of overactive bladder, a chronic condition characterized by symptoms of urge urinary incontinence (sudden and involuntary loss of bladder control resulting in wetting accidents), urgency (urgent need to empty the bladder) and frequency (frequent urination). Ditropan XL was introduced by ALZA in the United States in February 1999 and has captured 24 percent of the market for overactive bladder treatments. Sanofi-Synthelabo currently markets an immediate-release oral formulation of oxybutynin, which is taken two-to-four times daily, and is sold as Ditropan in most European markets. In clinical trials, patients treated with Ditropan XL reported an 83 percent - 90 percent reduction in their mean weekly urge incontinence episodes. Ditropan XL was demonstrated to be generally well-tolerated in patients. The most common side effects observed were dry mouth, constipation, drowsiness, diarrhea, blurred vision, dry eyes, dizziness and runny nose. Related Links: ALZA Corporation and Sanofi-Synthelabo. E-mail this page to a friend or colleague! To print, use this version