Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder
The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of
“FDA acceptance of our NDA for vibegron for the treatment of patients with OAB represents another important milestone for Urovant, and we look forward to working with the FDA during the NDA review period,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of
Sumitovant is a global biopharmaceutical company with offices in
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development and seek