APP Pharmaceuticals announces FDA marketing approval of Deferoxamine Mesylate

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 Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the reference-listed 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. APP's Deferoxamine Mesylate is AP-rated, bar-coded and latex-free. 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 transfusion-dependent anemias. In the case of acute iron poisoning, Deferoxamine Mesylate is most effective when given early in the treatment of iron poisoning. Long-term 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 company’s critical care product line. 


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