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www.fdanews.com/articles/97934-fda-grants-orphan-drug-designation-to-treanda

FDA Grants Orphan Drug Designation to Treanda

August 31, 2007

Cephalon announced that the FDA has granted orphan drug designation for Treanda, a treatment for chronic lymphocytic leukemia.

Cephalon said it plans to submit a new drug application to the FDA for Treanda (bendamustine HCl) in the third quarter.

The company added that it is also studying Treanda for the treatment of patients with slowly-progressing non-Hodgkin’s lymphoma who are refractory to the monoclonal antibody rituximab.