APP Pharmaceuticals Receives Approval For The First Generic Chlorothiazide Sodium For Injection, USP

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Oct 2009 - 5:00 PST

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced 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 http://www.APPpharma.com.

1 2008 IMS Data

Source
Fresenius Kabi AG

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