Vernalis and Tris Pharma receive FDA approval of NDA for Tuzistra™ XR

Industry News

The U.S. Food and Drug Administration has approved the New Drug Application for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III).  Tuzistra XR is codeveloped by Vernalis plc, headquartered in Winnersh, England and Tris Pharma, based in Monmouth Junction, NJ, USA.  According to the company, Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1(H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older.  This formulation extends codeine’s cough suppression duration and reduces the frequency of dosing compared to currently available short-acting formulation.


Subscribe to WXPress

Receive our newsletter and information on upcoming events.