Posted by Michael Wonder on 02 Jul 2017
Astellas submits supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
30 June 2017 - Astellas announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq and VESIcare, respectively. Each is approved by the FDA as a monotherapy for the treatment of overactive bladder with symptoms of urge urinary continence, urgency and urinary frequency.
