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FDA Approves Liquid Form of Cytarabine
SCHAUMBURG, Ill., Jan. 20 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of cytarabine injection, 2 g, 100 mg/mL liquid, 20 mL single-dose vials. The U.S. market for all dosages of cytarabine for injection in liquid and lyophilized forms was approximately $6 million in 2002.
"We believe cytarabine injection in the liquid form is the most desirable as it requires less handling prior to administration," said Patrick Soon-Shiong, M.D., APP chairman, president and chief executive officer. "Cytarabine injection is APP's first ANDA approval of 2004 and brings to 14 the number of anti-cancer products in the company's product offering. APP is committed to developing and providing a broad array of quality injectable products in the oncology, anti-infective and critical care areas."
The generic equivalent of Sicor, Inc.'s Cytosar-U®, cytarabine injection, in combination with other approved anti-cancer drugs, is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.
Source: American Pharmaceutical Partners, Inc.