Hanningfield Pages

Thursday, 22 October 2009

APP Pharmaceuticals Receives Approval for the First Generic Chlorothiazide Sodium for Injection, USP

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 LundbeckPharmaceuticals.
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.

Source: www.reuters.com