CORONA, Calif., June 23 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the Therapeutic Products Directorate of Health Canada has approved OXYTROL(R) (oxybutynin transdermal system), Watson's novel transdermal patch for the treatment of overactive bladder, with symptoms of urge urinary incontinence, urgency, and frequency.
OXYTROL(R) was accepted for regulatory review by the Therapeutic Products Directorate of Health Canada in May 2003. In January 2004, Watson announced that it had entered into a licensing agreement with Paladin Labs Inc. (TSX: PLB) to market OXYTROL(R) in Canada. Paladin Labs expects to launch the product in the fourth quarter 2004.
OXYTROL(R) was approved by the United States Food and Drug Administration (FDA) in February 2003 and was subsequently launched by Watson in April 2003. Watson's oxybutynin transdermal product also was granted European marketing authorization by the European Union's Commission of the European Communities in June 2004.
About OXYTROL(R)
OXYTROL(R) is a thin, flexible, clear patch that should be applied to the abdomen, hip or buttock twice weekly. The active ingredient in OXYTROL(R) is oxybutynin, a medication widely accepted and prescribed in oral formulation for the past 25 years. The OXYTROL(R) transdermal delivery system delivers 3.9 milligrams per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to four days.
The most common adverse events occurring with OXYTROL(R) 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(R) should not use OXYTROL(R).
For more information about OXYTROL(R), a detailed product profile is available at http://www.oxytrol.com/.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com/.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts about Watson are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, market acceptance of and continued demand for Watson's products, including the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals and actions; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2003 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2004.
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