SCHAUMBURG, Ill., Oct 29, 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 Metoprolol Tartrate Injection, USP, and expects to launch the medication soon.
Metoprolol Tartrate Injection, USP is therapeutically equivalent to the reference-listed drug Lopressor®, which is marketed by Novartis International AG. According to IMS Health, sales of this product in the United States for 2009 were approximately $13 million1.
"Heart disease is a leading cause of death in the United States and APP's approval of Metoprolol Tartrate Injection, USP, will provide an affordable, generic treatment for millions of patients who suffer a heart attack or acute myocardial infarction each year," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "Additionally, this approval further expands APP's growing Critical Care product line."
APP's Metoprolol Tartrate Injection, USP is AP-rated, preservative-free and bar-coded, and is packaged in single dose 5 mg/5 mL vials.
About Metoprolol Tartrate Injection, USP
Metoprolol Tartrate Injection, USP is the generic equivalent of Lopressor®. Metoprolol, commonly used in the treatment of acute myocardial infarction (AMI), is a selective beta1-adrenoreceptor blocking agent that is indicated in the treatment of hemodynamically stable patients with definite or suspected AMI to reduce cardiovascular mortality. Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows. Alternatively, treatment can begin within 3 to 10 days of the acute event. Please refer to the product package insert for Metoprolol Tartrate Injection, USP for further information regarding dosage and administration, contraindications, and other information about this medication.
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 http://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 http://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.
Lopressor® is marketed by Novartis International AG.
1 2009 IMS Dataview © IMS HEALTH.
SOURCE: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Media and Investor Relations:
Debra Lynn Ross, ABC
Director, Corporate Communications