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Septiembre 18, 2009
APP Pharmaceuticals Receives Approval For Deferoxamine Mesylate For Injection, USP
Filed Under (pharmacy) by admin

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQAPCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the referencelisted drug Desferal®, which is marketed by the innovator Novartis.

APP will package Deferoxamine Mesylate in single dose vials of 500 mg, 10 mL and 2 gram, 30 mL. APPs Deferoxamine Mesylate is APrated, barcoded and latexfree. According to IMS data, 2008 sales of this product in the United States were approximately $11.8 million1.

Deferoxamine Mesylate is an iron chelating agent that is used for iron poisoning as well as chronic iron overload due to transfusiondependent anemias. In the case of acute iron poisoning, Deferoxamine Mesylate is most effective when given early in the treatment of iron poisoning. Longterm treatment with Deferoxamine Mesylate has been shown to slow the accumulation of excess iron in the liver and can slow or eliminate the progression of a serious form of liver damage called liver fibrosis.

APP plans to launch Deferoxamine Mesylate in the fourth quarter of 2009, which will further expand the companys critical care product line.

About APP Pharmaceuticals, Inc.

APP Pharmaceuticals, Inc. is a fullyintegrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, antiinfective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, longterm 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 companys Web site at APPpharma.com.

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1 Comment posted on "APP Pharmaceuticals Receives Approval For Deferoxamine Mesylate For Injection, USP"
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