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FDA approves Enablex for treatment of overactive bladder

vailable in the United States, we have the potential to bring unique benefits to these patients whose needs are not currently met," stated Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation.

OAB, a condition that affects an estimated 33 million Americans, is caused by the untimely contraction of the bladder muscle. At least 16 percent of the population over the age of 40 suffers from the chronic and troublesome symptoms of OAB. Although prevalence increases with age, the problem affects people of all ages. People with OAB often limit travel, social and even work activities to avoid potentially embarrassing episodes that can occur with this condition.

"Millions of patients and their families can be profoundly affected by overactive bladder. It is important that we continue to advance technology to bring new options to people with overactive bladder to help them manage this condition," said Nancy Muller, executive director, National Association for Continence.

In total, Enablex has been studied in 98 clinical trials involving more than 10,000 people. In clinical trials, the most frequently reported adverse events associated with Enablex were dry mouth and constipation, however patient discontinuation rates due to these events were low. The majority of adverse events in Enablex treated subjects were mild or moderate and mostly occurred during the first two weeks of treatment. As with other OAB medications, Enablex is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Enablex is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.

This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business, which can be identified by the use of forward-looking terminology, such as "is expected," "will be," and "have the p
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22-Dec-2004


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