Tris Pharma receives FDA final approval for generic Tussionex ANDA

Oct 5 2010

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its licensing partner, Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration 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 5 mL).  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.  Annual U.S. sales of Tussionex® are approximately $226 million, according to IMS Health data.  

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

"We are pleased to have Par Pharmaceutical, one of the most respected generic pharmaceutical companies, as our partner in commercializing this unique opportunity," said Ketan Mehta, president and chief executive officer, Tris Pharma.

Par will begin shipping hydrocodone polistirex and chlorpheniramine polistirex (CIII) ER oral suspension to the trade immediately, but in limited supply due to Drug Enforcement Administration hydrocodone allocations.

In 2009, Par entered into a license and distribution agreement with Tris Pharma, Inc.  Under terms of the agreement, Par has the exclusive right to market, sell and distribute Tris Pharma's hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension in the U.S. and Par will receive a share of the profits from the sales of the product.

SOURCE Par Pharmaceutical Companies, Inc.