Allergan seeks wider indication at FDA/EU for Botox for Overactive Bladder - 29-Mar-2012

Allergan has submitted a supplemental BLA with the US FDA and an application with European regulatory authorities seeking approval of Botox as treatment for of overactive bladder with symptoms of urinary incontinence, urgency and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.The product recently gained approval for another urinary condition - urinary incontinence due to overactivity of the detrusor, or the bladder muscle, in patients with neurologic conditions such as spinal cord injury or multiple sclerosis not managed with anticholinergic treatment (Neurogenic Bladder).