Healthcare Industry News:  Aztreonam 

Biopharmaceuticals Generics FDA

 News Release - June 21, 2010

APP Pharmaceuticals Announces Approval and Launch of First Generic Aztreonam for Injection, USP

SCHAUMBURG, Ill.--(HSMN NewsFeed)--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 Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam®, which is marketed by Bristol-Myers Squibb.

APP will launch Aztreonam immediately in single dose vials of 1 gram, 20 mL and 2 gram, 30 mL. APP's Aztreonam is AP-rated, bar-coded and latex-free. According to IMS data, 2009 sales of the branded product in the United States were approximately $86 million1. The approval of Aztreonam further expands APP’s leading anti-infective product line.

“The approval of APP’s Aztreonam marks the first generic entrant into the market and provides clinicians with an alternative to the branded drug,” said John Ducker, president and chief executive officer of APP Pharmaceuticals. “APP’s entry into the market also provides hospitals with an additional source of supply for this anti-infective medication, which continues to be listed on the FDA and the American Society of Health-System Pharmacists (ASHP) drug shortage lists since the summer of 2009.”

About Aztreonam for Injection, USP

Aztreonam for Injection, USP is indicated for the treatment of infections caused by susceptible gram-negative microorganisms, including urinary tract infections, lower respiratory tract infections, septicemia, skin and skin-structure infections including those associated with postoperative wounds, ulcers and burns, intra-abdominal infections and gynecologic infections. It is also indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms.

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.

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. 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.

Azactam® is a registered trademark of Bristol-Myers Squibb Company

1 2009 IMS Dataview © IMS Health


Source: APP Pharmaceuticals

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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