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news.Par Pharmaceutical has said that its licensing partner Tris Pharma has got US Food and Drug Administration's (FDA) final approval for its abbreviated new drug application for Hydrocodone Polistirex and Chlorpheniramine Polistirex (CIII) extended-release (ER) oral suspension (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5ml).
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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.