FDA approves APP Pharmaceuticals' Idarubicin HCI injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ:APCVZ), announced today that it has received approval from the US Food and Drug Administration (FDA) to market idarubicin hydrochloride injection in three dosage strengths (5mg/5mL, 10mg/10mL and 20mg/20mL). Idarubicin is therapeutically equivalent to the reference drug Idamycin PFS injection, which is marketed by the innovator Pfizer, Inc.

APP will package Idarubicin in 5mL, 10mL and 20mL dose vials and expects to launch in September 2009. APP's Idarubicin is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States across all formulations and manufacturers were approximately $18.6 million.

Idarubicin belongs to a class of drugs called anthracyclines and is the foundation of many chemotherapy regimens. It is indicated for use as a therapy in patients with acute myeloid leukemia. Idarubicin, a cytotoxic agent, works by inhibiting activities of the cancer cell necessary for life and growth, which prevents the cancer cell from reproducing and results in death of the cancer cell.

“Idarubicin is an important addition to APP’s broad oncology portfolio,” said Thomas H. Silberg, president and chief executive officer of APP Pharmaceuticals. "We are looking forward to launching Idarubicin within the next month and have already secured a sole source contract position with a major group purchasing organization (GPO).”

http://www.apppharma.com/