Watson Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's resubmitted New Drug Application (NDA) for Oxytrol (oxybutynin transdermal system). The NDA seeks marketing approval for the use of Oxytrol in the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency.
The submission contains two Phase III clinical trials and a pharmacodynamic trial. The FDA has provided the Company with a primary user fee goal date of February 28, 2003 for a response on the application.