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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Thalidomide
Trade Name: Thalomid
Date Designated: 07/26/1995
Orphan Designation: Treatment of erythema nodosum leprosum.
Orphan Designation Status: Designated/Approved
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
United States

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

Marketing approved:

1 Generic Name: Thalidomide
Trade Name: Thalomid
Marketing Approval Date: 07/16/1998
Approved Labeled Indication: Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences.
Exclusivity End Date: 07/16/2005 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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