Watson Oxytrol approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Watson is stressing the favorable side effect profile of its overactive bladder patch Oxytrol compared to oral anticholinergic medications like Pharmacia's Detrol LA (tolterodine) and Alza's Ditropan XL (oxybutynin). FDA approved Watson's oxybutynin transdermal system Feb. 26 for treatment of OAB with symptoms of urge urinary incontinence, urgency and frequency. Labeling notes that "in two pivotal studies, no patient discontinued Oxytrol treatment due to dry mouth." Detrol and Ditropan labeling note discontinuation rates of 2.4% and 1.2%, respectively. The Oxytrol patch delivers 3.9 mg oxybutynin per day for up to four day
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