Generic launch of the leading intravenous antibiotic in the U.S.
SCHAUMBURG, Ill. (BUSINESS WIRE)—June 1, 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 to market Piperacillin and Tazobactam for Injection, the number one prescribed intravenous antibiotic in the U.S. APP will launch the product immediately.
Piperacillin and Tazobactam for Injection is therapeutically equivalent to the reference-listed drug Zosyn®, which is marketed by Pfizer Injectables. According to IMS data, 2010 sales of the branded product in the United States were approximately $750 million1. Piperacillin and Tazobactam is a broad spectrum injectable antibiotic with a range of activity against gram-positive and gram-negative aerobic and anaerobic organisms.
"APP’s approval of the number one prescribed injectable anti-infective enables us to continue our commitment of bringing affordable medications to hospitals, clinics and long-term care facilities throughout the U.S.,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “This approval further expands one of the most comprehensive and cost-effective portfolios of anti-infective injectable products in the industry.”
APP will package Piperacillin and Tazobactam for Injection in 2.25 g, 3.375 g and 4.5 g single dose vials, and in a 40.5 g pharmacy bulk package. APP's Piperacillin and Tazobactam for Injection is AP-rated, preservative free, latex free, bar-coded, and incorporates easy to read product and dosage information.
About Piperacillin and Tazobactam for Injection
Piperacillin and Tazobactam for Injection, is a broad spectrum injectable antibiotic, consisting of a beta-lactamase inhibitor, tazobactam, in combination with an extended-spectrum penicillin, piperacillin, a broad-spectrum, beta-lactam antibiotic. It is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, susceptible strains of indicated organisms, to treat appendicitis (complicated by rupture or abscess) and peritonitis, uncomplicated and complicated skin and skin structure infections, postpartum endometritis or PID, community-acquired pneumonia of moderate severity only, and nosocomial pneumonia (moderate to severe).
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.
Debra Lynn Ross, ABC
Director, Corporate Communications
APP Pharmaceuticals, Inc.
Zosyn® is a registered trademark of Wyeth Pharmaceuticals Inc.
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