(RTTNews) - Fresenius Kabi Pharmaceuticals Holdings Inc.'s (APCVZ: News ) subsidiary APP Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration to market its oncology product, idarubicin hydrochloride injection in three dosage strengths -- 5mg/5mL, 10mg/10mL and 20mg/20mL.

Idarubicin belongs to a class of drugs called anthracyclines and is indicated for use as a therapy in patients with acute myeloid leukemia.

Idarubicin hydrochloride is already available as intravenous powder for solution in strengths of 5 mg, 10 mg and 20 mg and as an intravenous solution in strength of 1 mg/ml. According to IMS data, 2008 sales of Idarubicin hydrochloride in the United States across all formulations and manufacturers were approximately $18.6 million.

The company noted that it has already secured a sole source contract position with a major group purchasing organization for Idarubicin hydrochloride injection and is planning to launch the product in September.
Fresenius Kabi made its foray into the U.S. pharmaceuticals market through its acquisition of APP Pharmaceuticals for $23 per share or a total value of $4.6 billion. The transaction was closed last September.

In 2008, Fresenius Kabi achieved sales of EUR 2,495 million and for the first half of 2009, reported sales of EUR 1,500 million, an increase of 34% over the comparable period a year before. Looking ahead to 2009, the company expects sales to grow 25% to 30 % on constant currency basis.

APCVZ, which has thus far hit a 52-week low of $0.18 and 52-week high of $2.20, closed Friday's trade at $0.22.

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by RTT Staff Writer

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