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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 for 50ml admixture
Trade Name: Bendeka
Date Designated: 07/02/2014
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
Eagle Pharmaceuticals, Inc.
50 Tice Blvd
Suite 315
Woodcliff Lake, New Jersey 07677
United States

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

Marketing approved:

1 Generic Name: bendamustine for 50ml admixture
Trade Name: Bendeka
Marketing Approval Date: 12/07/2015
Approved Labeled Indication: Treatment of patients with 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: 12/07/2022 
Exclusivity Protected Indication* :  Treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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