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FDA approves new leukemia drug

Published: March 20, 2008 at 2:46 PM
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WASHINGTON, March 20 (UPI) -- The U.S. Food and Drug Administration has approved a new injectable drug, Treanda, for the treatment of chronic lymphocytic leukemia.

Pharmaceutical manufacturer Cephalon Inc. (NASDAQ:CEPH) of Frazer, Pa., said Treanda (bendamustine hydrochloride) received priority review by the FDA and was approved within six months of the company's application.

Chronic lymphocytic leukemia, or CLL, is a slowly progressing blood and bone marrow disease. The American Cancer Society estimates more than 15,000 new cases of the rare disease will be diagnosed in the United States this year.

Cephalon officials said they anticipate Treanda will become available to physicians and patients as a CLL treatment in the United States next month.

Treanda has also been granted orphan drug status by the FDA, thereby providing Cephalon with marketing exclusivity until March 2015.



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