Merck has received FDA approval for an over-the-counter (OTC) treatment for overactive bladder (OAB) in women, Oxytrol for women.
Various studies demonstrated a woman's ability to recognize OAB symptoms, understand vital safety information on the label, judge the necessity of the product use and fittingly use Oxytrol for women (oxybutynin transdermal system, 3.9mg/day) on their own.
The approval allows the partial switch of Oxytrol from prescription to OTC as it will remain available only by prescription for OAB treatment in men.
Merck Consumer Care executive vice president and president Bridgette Heller said, "We are proud to bring OXYTROL FOR WOMEN over-the-counter and provide a treatment option that can help women with OAB recognize and treat their symptoms."
Company expects to make Oxytrol for women available in fall 2013.
