Search Orphan Drug Designations and Approvals
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Generic Name: | inotuzumab ozogamicin | ||||||||||||||||
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Trade Name: | |||||||||||||||||
Date Designated: | 03/25/2013 | ||||||||||||||||
Orphan Designation: | Treatment of B-cell acute lymphoblastic leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Wyeth Pharmaceuticals, LLC P.O. Box 8299 Philadelphia, Pennsylvania 19101 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: | inotuzumab ozogamicin |
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Trade Name: | ||
Marketing Approval Date: | 08/17/2017 | |
Approved Labeled Indication: | Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) | |
Exclusivity End Date: | 08/17/2024 | |
Exclusivity Protected Indication* : | Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) | |
2 | Generic Name: | inotuzumab ozogamicin |
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Trade Name: | Besponsa | |
Marketing Approval Date: | 03/06/2024 | |
Approved Labeled Indication: | treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older | |
Exclusivity End Date: | 03/06/2031 | |
Exclusivity Protected Indication* : | treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients 1 year and older | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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