SCHAUMBURG, Ill.--(BUSINESS WIRE)-- 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 to market Nafcillin for Injection, USP in three dosage strengths. APP’s Nafcillin for Injection, USP is therapeutically equivalent to the reference-listed drugs Unipen® (marketed by Wyeth) and Nallpen® (marketed by GlaxoSmithKline). Both companies have discontinued marketing these products.
APP will market Nafcillin in 1 gram and 2 gram single dose vials, and a 10 gram pharmacy bulk package. APP's Nafcillin is AP-rated, preservative-free and bar-coded. According to IMS data, 2010 product sales in the United States were approximately $59 million1.
“The approval of APP’s Nafcillin provides clinicians with a new supplier of this commonly used anti-infective medication,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “With the addition of Nafcillin, APP continues to expand its leading anti-infective portfolio.”
About Nafcillin for Injection, USP
Nafcillin for Injection, USP is indicated for the treatment of infections caused by penicillinase-producing staphylococci that have demonstrated susceptibility to the drug. Nafcillin and other drugs in its antibiotic class are particularly useful for the treatment of infections involving penicillinase-producing strains of Staphylococcus aureus, because they are highly resistant to inactivation by the enzyme penicillinase (beta-lactamase). Examples of common infections caused by Staphylococcus aureas include skin and soft tissue infections, osteomyelitis, endocarditis, and septicemia. Nafcillin is also active against nonpenicillinase-producing Staphylococcus aureus and against a variety of other bacteria.
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
Unipen® is a trademark of Wyeth and Nallpen® is a trademark of GlaxoSmithKline.
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications
KEYWORDS: United States North America Illinois
INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Oncology Pharmaceutical FDA General Health