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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: 11/26/2013
Orphan Designation: Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma)
Orphan Designation Status: Designated/Approved
Cephalon, Inc.
A wholly owned subsidiary of Teva Pharmaceuticals
PO Box 4011
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: 10/31/2008
Approved Labeled Indication: Treatment of Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Exclusivity End Date: 10/31/2015 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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