SCHAUMBURG, Ill. (BUSINESS WIRE)—July 11, 2011—APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Clonidine Hydrochloride Injection, in two dosage strengths. Clonidine Hydrochloride Injection is therapeutically equivalent to the reference-listed drug Duraclon®, currently marketed by the innovator Astellas U.S. Holding, Inc. (formerly Yamanouchi U.S. Holding Inc.).
APP will launch Clonidine Hydrochloride Injection immediately and market the analgesic in 1000 mcg/10 ml and 5000 mcg/10 ml single dose vials. APP's Clonidine Hydrochloride Injection is AP-rated, preservative-free and bar-coded. According to IMS data, 2010 product sales in the United States were approximately $3.13 million.
“The approval of APP’s Clonidine Hydrochloride further strengthens the company’s analgesic portfolio of products and helps solidify our continued leadership as a leading generic injectable company,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals.
About Clonidine Hydrochloride Injection
Clonidine Hydrochloride is a centrally-acting analgesic, which is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain. The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks.
About APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the anti-infective, anesthetic/analgesic, critical care and oncology markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the company’s Web site at www.APPpharma.com.
About Fresenius Kabi AG
Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Fresenius Kabi’s core product range includes infusion solutions, blood volume substitutes, I.V. drugs and parenteral nutrition, as well as products for enteral nutrition. Furthermore, the company provides concepts for ambulatory health care and is focused on managing and providing home therapies. With the philosophy “caring for life” and a comprehensive product portfolio, the company aims at improving the quality of life of critically and chronically ill patients all over the world. In 2010, Fresenius Kabi achieved sales of EUR 3,672 million and an operating profit of EUR 737 million. For more information visit the company’s Web site at www.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE & Co. KGaA.
The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of our products. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2010 and other documents the company has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this release. Fresenius Kabi Pharmaceuticals Holding, Inc. does not assume any obligation to update or revise these forward-looking statements to conform the statement to actual results, new information, developments or changes in the Company’s expectations.
1 2010 IMS Dataview © IMS HEALTH
Duraclon® is a registered trademark of Astellas U.S. Holding, Inc. (formerly Yamanouchi U.S. Holding Inc.).
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.