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Watson Pharma’s Oxytrol gets positive opinion for approval in EU
California | Monday, December 1, 2003, 08:00 Hrs  [IST]

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that the European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Proprietary Medicinal Products (CPMP) provided a positive opinion on the company's European marketing authorization application for its oxybutynin transdermal product for the treatment of overactive bladder. The CPMP opinion serves as the basis for a European Commission approval, which is typically issued in approximately three months. The EMEA initiated review of the application on February 24, 2003 as part of a qualified centralized procedure.

Watson currently markets the product in the United States under the name Oxytrol. Oxytrol is the first and only transdermal therapy for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. On September 24, 2003, the company announced that it had entered into a marketing and supply agreement with UCB Pharma, pursuant to which UCB Pharma will market the oxybutynin transdermal product in Europe.

Oxytrol is a thin, flexible and clear patch applied to the abdomen, hip or buttock twice weekly. The Oxytrol transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously. Oxytrol offers OAB patients proven efficacy and a low incidence of anticholinergic side effects, such as dry mouth and constipation. In clinical studies, the difference in dry mouth, constipation and dizziness between Oxytrol and placebo was not statistically significant. The most common adverse events occurring with Oxytrol were application site reactions, dry mouth, constipation, diarrhea, dysuria and abnormal vision. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to oxybutynin or other components of Oxytrol should not use Oxytrol.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

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