FDA Approves Cough, Cold Drug From Vernalis, Tris Pharma

Vernalis Plc and Tris Pharma Inc. May 1 announced that the Food and Drug Administration has approved Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III).

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 common cold in adults aged 18 years and older, the companies said. It is indicated for oral use, with or without food, and is to be dosed every 12 hours.

The Drug Enforcement Administration has placed ...