Leukemia

FDA approval granted for liquid form of cytarabine injection

Published in Blood Weekly, February 19th, 2004

American Pharmaceutical Partners, Inc., (APPX) 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, MD, APP chairman, president and chief executive officer. "Cytarabine injection is APP's first ANDA approval of 2004...

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Source: Blood Weekly (2004-02-19)

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