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# FDA Accepts Astellas sNDA for Overactive Bladder Drug Combo
- URL: https://www.fdaweb.com/fda-accepts-astellas-snda-for-overactive-bladder-drug-combo/
- Published: 2017-09-13T12:00:00.000Z
- Updated: 2026-09-14T22:49:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139620

FDA has accepted for review an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the U.S., Myrbetriq (mirabegron) and VESIcare (solifenacin succinate) are individually marketed as monotherapy for treating OAB with symptoms of urge urinary continence, urgency and urinary frequency. The agency has set a user fee review target date of 4/28/2018.

The submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These included more than 5,000 patients with OAB and evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.