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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  moxetumomab pasudotox-tdfk
Trade Name:  LUMOXITI
Date Designated:  11/15/2007
Orphan Designation:  Treatment of hairy cell leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/13/2018 
Approved Labeled Indication:  LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Exclusivity End Date:    09/13/2025 
Exclusivity Protected Indication* :  LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
AstraZeneca Pharmaceuticals LP
1800 Concord Pike PO Box 8355
Wilmington, Delaware 19803-8355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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