News
Urovant Sciences announces FDA acceptance of NDA for vibegron for the treatment of overactive bladder.
Urovant Sciences announced that the 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 26 December 2020.
In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
Condition: Overactive Bladder
Type: drug
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