FDA approval for Cladribine to treat active Hairy Cell Leukemia

Apr 27 2004

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(R) 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."

American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. APP has acquired the exclusive North American rights to manufacture and market ABRAXANE(TM), a proprietary nanoparticle injectable oncology product that has completed Phase III clinical trials for metastatic breast cancer and for which the FDA has granted "Fast Track" designation. The NDA submission was completed in March 2004.

The company believes that it has established the only commercial scale protein-engineered nanoparticle manufacturing capability in the United States. For more information, visit APP's website at http://www.appdrugs.com.