GEMTESA is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences
U.S. commercial launch planned in late-Q1 2021
San Francisco, CA (UroToday.com) — Urovant Sciences announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.