FDA approves NDA for Tuzistra XR

1 May 2015

Shares of UK biotech firm Vernalis (LSE: VER) rose 15.12% to 59.00 pence by midday Friday, Friday after it revealed that the US 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), which is partnered with privately-held USA-based Tris Pharma.

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. It is indicated for oral use, with or without food, and is to be dosed every 12 hours.

Will enter a $3 billion market sector

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