FDA approves Par and Tris Pharma's generic Tussionex

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic treatment for cough and upper respiratory symptoms resulting from colds and allergies made by Par Pharmaceutical and Tris Pharma, Par said Tuesday.

The FDA approved hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension. The drug is a generic version of UCB’s Tussionex, which has annual sales of around $226 million, according to IMS Health.

“The introduction of this first-to-market generic product will improve patient access to a much-needed therapy,” Par EVP and president Paul Campanelli said. “Our partner, Tris Pharma, has once again leveraged its innovative drug-delivery platform to bring this important product market.”