SCHAUMBURG, Ill., Jun 22, 2010 (BUSINESS WIRE) --APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene (R)-IV, which is marketed by Roche Laboratories, Inc.
APP will soon launch Ganciclovir for Injection and will package the product in single dose, 500 mg vials. APP's Ganciclovir for Injection is AP-rated, latex-free and bar-coded. According to IMS Health, sales of this product for 2009 in the United States were approximately $13.5 million1.
Ganciclovir for Injection is an antiviral drug, which is used in the treatment of Cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), as well as for the prevention of CMV disease in transplant recipients at risk for CMV disease. CMV disease is a serious illness that can lead to blindness, transplant graft loss and potential loss of life.
"This approval reinforces APP's commitment to provide our customers, and the patients they treat, with a consistently expanding portfolio of products," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "The addition of Ganciclovir for Injection further strengthens APP's broad anti-infective portfolio and market leadership position."
About Ganciclovir for Injection, USP
Ganciclovir for Injection is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Ganciclovir for Injection is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease. SAFETY AND EFFICACY OF GANCICLOVIR FOR INJECTION HAS NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE, NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS, NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS.
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 2009, Fresenius Kabi achieved sales of EUR 3,086 million and an operating profit of EUR 607 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.
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. Additional relevant information concerning risks are discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2009 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.
Cytovene(R)-IV is a registered trademark of Roche Laboratories, Inc.
1 Per IMS Dataview © IMS Health as of December 31, 2009
SOURCE: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications