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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Bexarotene
Trade Name: Targretin
Date Designated: 06/18/1999
Orphan Designation: Treatment of cutaneous T-cell lymphoma.
Orphan Designation Status: Designated/Approved
Eisai, Inc.
300 Tice Blvd
Woodcliff Lake, New Jersey 07677
United States

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

Marketing approved:

1 Generic Name: Bexarotene
Trade Name: Targretin
Marketing Approval Date: 12/29/1999
Approved Labeled Indication: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Exclusivity End Date: 12/29/2006 
Exclusivity Protected Indication* :  

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