WOODCLIFF LAKE, N.J., Oct. 5 /PRNewswire-FirstCall/ -- 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.
Important information about hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension
Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age or older.
Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
The use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this news release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, in other of the Company’s filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical Companies, Inc.
