The FDA green lighted Gemtesa (vibegron), developed by Urovant Sciences Ltd. (UROV), on December 23, 2020 for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.OAB is a clinical condition caused by involuntary contraction of the bladder muscle.Gemtesa is a small-molecule ß3 agonist which helps relax the detrusor bladder muscle, enabling the bladder to hold more urine, thereby reducing symptoms of OAB.This approval marks the first new oral branded OAB medication approved by the FDA since 2012. Astella's Myrbetriq was approved in 2012 for the same indication.The most common adverse reactions of Gemtesa were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.Urovant is planning to launch Gemtesa late in the first quarter of 2021. The drug is already approved in Japan.