FDA to Review Tuzistra XR NDA for Cough Cold
Vernalis and Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Tuzistra XR (CCP-01) in the acute treatment of cough cold.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of April 30, 2015.
Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra XR represents the first product within this pipeline to reach NDA stage.