Watson Pharmaceuticals Inc has filed a European Marketing Authorization Application seeking European marketing approval for Oxytrol (oxybutynin transdermal system) as part of a qualified centralized procedure with the European Medicines Control Agency (EMEA), which consists of 15 member states. Oxytrol, recently approved by the U.S. Food and Drug Administration, is the first and only transdermal therapy indicated for the treatment of overactive bladder (OAB), including symptoms of urge incontinence, urgency and frequency.
"We are very pleased that our Oxytrol European application has been accepted for filing," began Allen Chao, Chairman and Chief Executive Officer. "With overactive bladder affecting an estimated 28 million Europeans, Europe is clearly an important market. Over the next 60 days, we will be actively pursuing partnering opportunities for the commercialization of Oxytrol in Europe."