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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
Trade Name: Novantrone
Date Designated: 08/21/1996
Orphan Designation: Treatment of hormone refractory prostate cancer.
Orphan Designation Status: Designated/Approved
One Technology Place
Rockland, Massachusetts 02370
United States

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

Marketing approved:

1 Generic Name: Mitoxantrone
Trade Name: Novantrone
Marketing Approval Date: 11/13/1996
Approved Labeled Indication: In combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.
Exclusivity End Date: 11/13/2003 
Exclusivity Protected Indication* :  

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