SCHAUMBURG, Ill. (BUSINESS WIRE)—July 5, 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) for Levothyroxine Sodium for Injection. Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma, a life-threatening complication of hypothyroidism.
As the sole manufacturer of Levothyroxine Sodium for Injection, APP Pharmaceuticals will be introducing an extension of its current product line in the next several months. In 2010, IMS Data indicated the market size for Levothyroxine Sodium for Injection was $26.9 million with 939,000 units of all strengths sold.
“APP worked closely with the FDA to secure approval of Levothyroxine Sodium for Injection because of the expressed medical need for this drug,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “We will continue to collaborate with the FDA to gain approval of established and much needed drugs that maintain the highest standards of quality, safety and efficacy.”
APP Pharmaceuticals' Levothyroxine Sodium for Injection will be marketed in single dose 100 mcg, 200 mcg, and 500 mcg vials.
About Levothyroxine Sodium for Injection
Levothyroxine Sodium for Injection is an l-thyroxine product indicated for the treatment of myxedema coma, which produces a gradual increase in the circulating concentrations of levothyroxine (T4) in hypothyroid patients.
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 oncology, anti-infective, anesthetic/analgesic and critical care 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
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.