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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bortezomib
Trade Name: Velcade
Date Designated: 05/30/2012
Orphan Designation: Treatment of mantle cell lymphoma.
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: bortezomib
Trade Name: Velcade
Marketing Approval Date: 12/08/2006
Approved Labeled Indication: Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.
Exclusivity End Date: 12/08/2013 
Exclusivity Protected Indication* :  
2 Generic Name: bortezomib
Trade Name: Velcade
Marketing Approval Date: 10/08/2014
Approved Labeled Indication: Treatment of patients with mantle cell lymphoma.
Exclusivity End Date: 10/08/2021 
Exclusivity Protected Indication* :  Treatment of patients with mantle cell lymphoma who have not received at least 1 prior therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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