Tuzistra XR regulatory update

Tris submitted an NDA to FDA for Tuzistra XR for the acute treatment of cough and cold. Tris and commercialization partner Vernalis plc (LSE:VER, Winnersh, U.K.) said acceptance of the NDA will trigger 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.

Tuzistra XR is an extended-release formulation of an undisclosed existing cough and cold product. Tris submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...