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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: inotuzumab ozogamicin
Trade Name:
Date Designated: 03/25/2013
Orphan Designation: Treatment of B-cell acute lymphoblastic leukemia
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: inotuzumab ozogamicin
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
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
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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