ARTICLE | Clinical News

Tuzistra XR regulatory update

September 29, 2014 7:00 AM UTC

Tris and Vernalis plc (LSE:VER, Winnersh, U.K.) said FDA accepted for review an NDA for Tuzistra XR for the acute treatment of cough and cold. The PDUFA date is April 30, 2015. The NDA acceptance triggered an undisclosed milestone to Tris under a February 2012 deal granting Vernalis exclusive, North American rights to commercialize up to 6 reformulated prescription cough and cold products using Tris' OralXR+ extended-release formulation technology (see BioCentury, Feb. 13, 2012 & July 5, 2014). Vernalis hopes to launch Tuzistra XR "ahead of the 2015-16 cough cold season." ...