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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: 01/15/2003
Orphan Designation: Treatment of multiple myeloma
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: 05/13/2003
Approved Labeled Indication: Treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy
Exclusivity End Date: 05/13/2010 
Exclusivity Protected Indication* :  
2 Generic Name: bortezomib
Trade Name: Velcade
Marketing Approval Date: 03/25/2005
Approved Labeled Indication: Treatment of multiple myeloma patients who have received at least one prior therapy
Exclusivity End Date: 03/25/2012 
Exclusivity Protected Indication* :  
3 Generic Name: bortezomib
Trade Name: Velcade
Marketing Approval Date: 06/20/2008
Approved Labeled Indication: First-line therapy of multiple myeloma.
Exclusivity End Date: 06/20/2015 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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