The approval was based on safety and efficacy data from two double-blind, randomized, multi-center trials conducted in adults whose OAB symptoms were not managed using anticholinergic treatments.
Allergan research and development executive vice president, chief scientific officer Scott Whitcup said Botox is at present approved for 26 diverse indications in more than 85 countries.
"Most importantly, today’s FDA approval is a milestone in the treatment of this burdensome condition and will provide a novel option for urologists and their OAB patients," Whitcup added.
The placebo-controlled trials of 24 week long demonstrated that Botox condensed daily urinary incontinence episodes by 50% or more by week 12 compared to placebo.