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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Bendamustine hydrochloride
Trade Name: Treanda
Date Designated: 08/17/2007
Orphan Designation: Treatment of chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
Cephalon, Inc.
41 Moores Road
Frazer, Pennsylvania 19355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Bendamustine hydrochloride
Trade Name: Treanda
Marketing Approval Date: 03/20/2008
Approved Labeled Indication: Treatment of patients with chronic lymphocytic leukemia
Exclusivity End Date: 03/20/2015 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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