Ventrus Biosciences, Inc. (VTUS) Receives Date For Type B Pre-NDA Meeting With FDA For DOLIZEM (Diltiazem Hydrochloride Cream) In Anal Fissures
4/4/2014 7:42:43 AM
NEW YORK, April 4, 2014 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq:VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced that, in response to a request from the company, the U.S. Food and Drug Administration (FDA) has scheduled a Type B pre-NDA meeting on Thursday, June 19, 2014 at which the company will seek guidance on its planned new drug application (NDA) for DOLIZEM (diltiazem hydrochloride cream) in anal fissures. Ventrus would expect to file an NDA in the second half of 2014 with an anticipated PDUFA date in the second half of 2015 if there is a positive outcome of this pre-NDA meeting.
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