Pharmaceutical Business review

Tris Pharma gets FDA final approval for generic Tussionex ANDA

Hydrocodone Polistirex and Chlorpheniramine Polistirex (CIII) ER oral suspension is a generic version of UCB’s Tussionex, which is used for relief of cough and upper respiratory symptoms associated with allergy or a cold.

Par signed a license and distribution agreement with Tris Pharma in 2009, under which Par has the exclusive right to market, sell and distribute Tris Pharma’s Hydrocodone Polistirex and Chlorpheniramine Polistirex ER oral suspension in the US and Par will receive a share of the profits from the sales of the product.

Par expects to start shipping Hydrocodone Polistirex and Chlorpheniramine Polistirex (CIII) ER oral suspension to the trade immediately.

Par executive vice president and president Paul Campanelli the introduction of this first-to-market generic product will improve patient access to a much needed therapy.