Search Orphan Drug Designations and Approvals
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Generic Name: | Mitoxantrone | ||||||||||||||||
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Trade Name: | Novantrone | ||||||||||||||||
Date Designated: | 08/13/1999 | ||||||||||||||||
Orphan Designation: | Treatment of secondary-progressive multiple sclerosis. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Serono, Inc. One Technoloogy Place Rockland, Massachusetts 02370 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Mitoxantrone |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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