Search Orphan Drug Designations and Approvals
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Generic Name: | romidepsin | ||||||||||||||||
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Trade Name: | Istodax | ||||||||||||||||
Date Designated: | 09/30/2004 | ||||||||||||||||
Orphan Designation: | Treatment of non-Hodgkin T-cell lymphomas | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Celgene Corporation One Broadway 14th Floor Cambridge, Massachusetts 02142 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | romidepsin |
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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 |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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