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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 50 ml admixture
Trade Name: Bendeka
Date Designated: 07/02/2014
Orphan Designation: Treatment of chronic lymphocytic leukemia
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 50 ml admixture
Trade Name: Bendeka
Marketing Approval Date: 12/07/2015
Approved Labeled Indication: Treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.
Exclusivity End Date: 12/07/2022 
Exclusivity Protected Indication* :  Treatment of patients with CLL
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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