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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Alitretinoin
Trade Name:  Panretin
Date Designated:  03/24/1998
Orphan Designation:  Treatment of AIDS-related Kaposi's sarcoma.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/02/1999 
Approved Labeled Indication:  Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.
Exclusivity End Date:   02/02/2006
Exclusivity Protected Indication*:  
Eisai, Inc
300 Tice Blvd
Woodcliff Lake, New Jersey 07677

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.