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FDA approves new leukemia drug

Submitted by MT Bureau on Fri, 03/21/2008 - 07:31. ::

Washington -- The U.S. Food and Drug Administration has approved a new injectable drug, Treanda, for the treatment of chronic lymphocytic leukemia.

FDA approves new leukemia drugGet original file (7KB)

Pharmaceutical manufacturer Cephalon Inc. 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.

Copyright 2008 by United Press International.

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