FDA accepts Urovant's vibegron NDA in overactive bladder

6 March 2020

Urovant Sciences (Nasdaq: UROV) has had its New Drug Application (NDA) for the overactive bladder candidate vibegron accepted by the US Food and Drug Administration (FDA).

The company, which is a part of Sumitomo Dainippon Pharma (TYO: 4506) within a newly-created biotech called Sumitovant Biopharma, has been given a Prescription Drug User Fee Act goal date for its NDA of December 26 this year.

Drug under license from Merck & Co

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