On January 25, 2013 the US Food and Drug Administration (FDA) announced the approval of the Rx-to-OTC switch of oxybutynin in the form of Oxytrol® Transdermal System (TDS) for women suffering from overactive bladder (OAB). This represents a first-in-class switch for a chronic condition. The FDA’s decision to approve Oxytrol® For Women is an important advance in patient self-care1. This represents the culmination of an interactive review of the sponsor’s New Drug Application (NDA) and the FDA’s considerations of the deliberations of a public FDA Advisory Committee meeting on November 9, 2012. Oxytrol® Transdermal System remains a prescription product in other countries where it is marketed.
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