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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: 10/14/1998
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Celgene Corporation
P.O. Box 4914
7 Powder Horn Srive
Warren, New Jersey 07059
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: 05/25/2006
Approved Labeled Indication: Treatment of patients with newly diagnosed multiple myeloma
Exclusivity End Date: 05/25/2013 
Exclusivity Protected Indication* :  

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