Par Pharmaceutical & Aveva Drug Delivery Systems Receive Final Approval to Market Generic Catapres TTS(R)
WOODCLIFF LAKE, N.J., Aug. 18 /PRNewswire-FirstCall/ — Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for a clonidine transdermal system. Clonidine TDS is a generic version of Boehringer Ingelheim’s Catapres TTS((R)) and is the first generic seven-day patch indicated in the treatment of hypertension. Clonidine TDS is available in 0.1 mg/day, 0.2 mg/day and 0.3 mg/day strengths. Annual U.S. sales of Catapres TTS((R)) were approximately $297 million, according to IMS Health data. Par will begin shipping clonidine TDS to the trade in the near future.
Paul V. Campanelli, President of Par’s generic division, said, “We are very pleased to have received this critical approval. Par and Aveva have been working together tirelessly to bring this important product to market.”
“We appreciate Par’s support and commitment throughout the development effort and the extended approval process of this important first generic product,” stated Wallace Reams, President and Chief Operating Officer of Aveva Drug Delivery Systems.
Under the terms of its agreement with Aveva, Par has exclusive rights to market, sell and distribute Aveva’s clonidine TDS in the U.S. The product will be manufactured by Aveva, and the companies will share profits from the sales of the product.
Important information about clonidine TDS
Clonidine Transdermal System is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Clonidine Transdermal System should not be used in patients with known hypersensitivity to Clonidine or to any other component of the Transdermal system.
About Aveva Drug Delivery Systems
Aveva Drug Delivery Systems is a Nitto Denko company, which is one of the world’s largest manufacturers of and a pioneer in transdermal drug delivery systems. Nitto Denko has a 40-year history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or are high-quality, low-cost brand equivalents. Leveraging this experience, Aveva offers a full range of research, development and manufacturing capabilities using a number of sophisticated technologies to produce proprietary and generic transdermal drug delivery systems that fortify R&D pipelines and maximize the life cycles of products. For press release and other company information visit www.avevadds.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release 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 Annual Report on Form 10-K for the year ended December 31, 2008, in Item 1A of the Company’s subsequent Quarterly Reports on Form 10-Q, in other of the Company’s filings with the SEC from time to time, including 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.