Search Orphan Drug Designations and Approvals
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| Generic Name: | Mitoxantrone | ||||||||||||||||
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| Trade Name: | Novantrone | ||||||||||||||||
| Date Designated: | 08/21/1996 | ||||||||||||||||
| Orphan Designation: | Treatment of hormone refractory prostate cancer. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Serono One Technology 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: | 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* : | ||
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