APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (APCVZ), Wednesday said it received approval from the U.S. Food and Drug Administration, or FDA, to market Chlorothiazide Sodium for Injection, USP. APP expects to launch the drug in the fourth quarter of 2009.
Schaumburg, Illinois-based APP will package Chlorothiazide Sodium injection in single dose vials of 500 mg. The drug is AP-rated, bar-coded and latex-free.
Chlorothiazide is a diuretic used to treat hypertension, or high blood pressure, and also fluid retention in people with congestive heart failure, cirrhosis of liver, kidney disorders, or edema caused by taking steroids or estrogen.
Chlorothiazide Sodium injection is therapeutically equivalent to reference-listed drug Diuril, marketed by Denmark-based Lundbeck Pharmaceuticals. Diuril is a diuretic and antihypertensive. According to 2008 IMS data, Diuril had sales of nearly $51 million in the U.S.
APP said Chlorothiazide has been shown to significantly lower systolic and diastolic blood pressure. In September 2008, APP was acquired by Germany-based Fresenius Kabi Pharmaceuticals.
APCVZ closed Tuesday's regular trading at $0.54 per share on the Nasdaq.
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