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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: 08/13/1999
Orphan Designation: Treatment of secondary-progressive multiple sclerosis.
Orphan Designation Status: Designated/Approved
Serono, Inc.
One Technoloogy 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: 10/13/2000
Approved Labeled Indication: Reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly adnormal between relapses).
Exclusivity End Date: 10/13/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.