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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Mitoxantrone HCl
Trade Name: Novantrone
Date Designated: 07/13/1987
Orphan Designation: Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.
Orphan Designation Status: Designated/Approved
Lederle Laboratories
Division of American Cyanamid Company
401 N. Middletown Road
Pearl River, New York 10965
United States

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

Marketing approved:

1 Generic Name: Mitoxantrone HCl
Trade Name: Novantrone
Marketing Approval Date: 12/23/1987
Approved Labeled Indication:
Exclusivity End Date: 12/23/1994 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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