APP Pharmaceuticals Announces Approval of Preservative-Free Methotrexate Injection, USP

APP Pharmaceuticals Announces Approval of Preservative-Free Methotrexate Injection, USP

February 22, 2012

SCHAUMBURG, Ill. (BUSINESS WIRE)—February 22, 2012—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 preservative-free Methotrexate Injection, USP. APP currently manufactures Methotrexate Injection with preservative. According to 2011 IMS data, last year there were approximately 1.8 million units sold in the United States of both formulations1.

Due to the nationwide shortage of preservative-free Methotrexate, APP worked collaboratively with the U.S. Food and Drug Administration to expedite approval of this critically needed oncology drug. Once APP received notification of the approval, the Company immediately began the process of quickly scheduling production so that APP can ship to customers within the next four to six weeks.

"APP is acutely aware of the pressure that oncologists are under when a critically needed cancer treatment is unavailable," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "By working collaboratively with the FDA, we have helped address several industry-wide shortages of critical generic sterile injectable chemotherapeutic agents. During the past year, a number of oncology drug suppliers have reduced output due to manufacturing issues causing significant disruption to availability. I am delighted that in many cases APP Pharmaceuticals has helped to minimize shortages by significantly increasing our production. This ability to respond rapidly is one of the key strengths of our U.S.-based manufacturing platform."

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

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 Fresenius Kabi AG is a 100% subsidiary of Fresenius SE & Co. KGaA.

Forward-Looking Statement

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 2011 IMS Dataview © IMS HEALTH

APP Contact
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.
(847) 969-8026