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.