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FDA Approves Cladribine Injection, Treatment for Hairy Cell Leukemia

SCHAUMBURG, Ill., April 27 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cladribine Injection. Cladribine is indicated for the treatment of active Hairy Cell Leukemia, and is the generic equivalent of Ortho Biotech's Leustatin® Injection. APP expects to commence marketing cladribine in the third quarter of this year.

"Sales of cladribine were approximately $9 million in 2003," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of American Pharmaceutical Partners. "Cladribine adds to our broad oncology product offering and brings to three the number of ANDA approvals APP has received thus far in 2004."

Source: American Pharmaceutical Partners, Inc.

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