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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vorinostat
Trade Name: Zolinza
Date Designated: 03/16/2004
Orphan Designation: Treatment of T-cell non-Hodgkin's lymphoma
Orphan Designation Status: Designated/Approved
Merck & Co., Inc.
P. O. Box 2000, RY 32-605
Rahway, New Jersey 07065
United States

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

Marketing approved:

1 Generic Name: vorinostat
Trade Name: Zolinza
Marketing Approval Date: 10/06/2006
Approved Labeled Indication: Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistant or recurrent disease on or following two systemic therapies.
Exclusivity End Date: 10/06/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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