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 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - Pharmaceutical News - FDA Accepts For Review Astellas' SNDA For Mirabegron - November 20, 2017

Pharmacy News Article

 9/13/17 - FDA Accepts For Review Astellas' SNDA For Mirabegron

TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application or sNDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder or OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act or PDUFA goal date for a decision by the FDA is April 28, 2018.

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 OAB with symptoms of urge urinary continence, urgency and urinary frequency.

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



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