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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
Date Designated: 05/01/1995
Orphan Designation: Treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.

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