SCHAUMBURG, Ill.--(BUSINESS WIRE)--Oct. 21, 2009-- 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 Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009.
Chlorothiazide Sodium for Injection, USP is therapeutically equivalent to the reference-listed drug Diuril®, which is marketed by Lundbeck Pharmaceuticals. According to 2008 IMS data, sales of this product in the United States were approximately $51 million1. Chlorothiazide is a diuretic used to treat high blood pressure (hypertension), as well as fluid retention in people with congestive heart failure, cirrhosis of the liver, kidney disorders, or edema caused by taking steroids or estrogen.
“The recent stream of ANDA approvals reinforces APP’s commitment to provide our customers and the patients they treat with a consistently expanding portfolio of products,” said Thomas H. Silberg, president and chief executive officer of APP Pharmaceuticals.
APP will package Chlorothiazide Sodium for Injection, USP in single dose vials of 500 mg. APP's Chlorothiazide Sodium for Injection, USP is AP-rated, bar-coded and latex-free.
About Chlorothiazide Sodium for Injection, USP
Chlorothiazide Sodium for Injection, USP is used to treat several conditions, including high blood pressure (hypertension) and water retention (edema) caused by estrogen, corticosteroids, congestive heart failure, cirrhosis of the liver, kidney disease or kidney failure (renal failure). Chlorothiazide has been shown to significantly lower systolic and diastolic blood pressure. By lowering blood pressure, the drug can decrease the risk of developing health problems (such as a stroke, heart disease, or congestive heart failure) that may occur with long-term high blood pressure.
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 for fluid substitution, blood volume expansion, 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 patients all over the world. In 2008, Fresenius Kabi achieved sales of EUR 2,495 million and an operating profit of EUR 443 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. Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approximately EUR 12.3 billion. For more information visit the company’s Web site at www.fresenius.com.
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 Chlorothiazide Sodium for Injection, USP. 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, 2008 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.
Diuril® is a registered trademark of Merck & Company, Inc.
1 2008 IMS Data
Source: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
Hill & Knowlton