FDA approves Watson Pharmaceuticals' Oxytrol patch

by Medindia Content Team on  March 22, 2003 at 12:11 PM Drug News
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FDA approves Watson Pharmaceuticals' Oxytrol patch
The Food and Drug Administration has approved a new patch developed by Watson Pharmaceuticals Inc., for the treatment of an overactive bladder. The patch called Oxytrol (generic: oxybutynin transdermal system) reduces urinary urge incontinence, urinary urgency, and urinary frequency, according to the drug's maker. Oral forms of oxybutynin has been around for around 25 years but it has not been popular with patients due to side effects like dry mouth and constipation. The patch delivers about 3.9mg of oxybutynin per day through a transdermal delivery system i.e., through the skin. The patch which needs to be applied to the abdomen, hip or buttocks twice a week helps better management of the side effects. The only side effect that the patch produced was itching in 14% to 16.8% of patients during the clinical trials. However, oxytrol is not recommended for patients who are at a risk of urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. The drug which will be available in the market by the end of May 2003 was approved after clinical trials involving more than 1000 people.


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