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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: romidepsin
Trade Name: Istodax
Date Designated: 09/30/2004
Orphan Designation: Treatment of non-Hodgkin T-cell lymphomas
Orphan Designation Status: Designated/Approved
Celgene Corporation
One Broadway
14th Floor
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: romidepsin
Trade Name: Istodax
Marketing Approval Date: 11/05/2009
Approved Labeled Indication: Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy
Exclusivity End Date: 11/05/2016 
Exclusivity Protected Indication* :  
2 Generic Name: romidepsin
Trade Name: Istodax
Marketing Approval Date: 06/16/2011
Approved Labeled Indication: Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy
Exclusivity End Date: 06/16/2018 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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