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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Tretinoin
Trade Name: Vesanoid
Date Designated: 10/24/1990
Orphan Designation: Treatment of acute promyelocytic leukemia.
Orphan Designation Status: Designated/Approved
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, New Jersey 07110
United States

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

Marketing approved:

1 Generic Name: Tretinoin
Trade Name: Vesanoid
Marketing Approval Date: 11/22/1995
Approved Labeled Indication: Induction of remission in patients with acute promyelocytic leukemia who are refractory to or unable to tolerate anthracycline based cytotoxic chemotherapeutic regimens.
Exclusivity End Date: 11/22/2002 
Exclusivity Protected Indication* :  

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