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.