Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.
Source: Businesswire, March 5, 2020