Thursday, APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (APCVZ), said it has obtained approval from the U.S. Food and Drug Administration, or FDA, to market Deferoxamine Mesylate for injection, USP, in two dosage strengths. Besides, the company announced plans to launch Deferoxamine Mesylate in the fourth quarter of 2009, and expects the same to further expand its critical care product line.
Deferoxamine Mesylate is an iron chelating agent that is used for iron poisoning as well as chronic iron overload due to transfusion-dependent anemias. Therapeutically, it is similar to the reference-listed drug Desferal, which is marketed by Novartis AG (NVS).
It has been proven that long-term treatment with Deferoxamine Mesylate will slow the accumultaion of excess iron in the liver and can slow or eliminate the progression of a serious form of liver damage called liver fibrosis.
The pharmaceutical company noted that it will pack Deferoxamine Mesylate in single dose vials of 500 mg, 10 mL and 2 gram, 30 mL. According to IMS data, the product recorded sales of $11.8 million in US in 2008.
APCVZ closed Wednesday's regular session at $0.62, down 0.03%, on a volume of 380K shares. In the after hours, the company's shares dropped $0.02 or 3.23% to $0.60.
NVS closed Wednesday's trade at $48.60, up $0.80 or 1.67%, on a volume of 1.57 million shares.
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