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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
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.

Marketing approved:

1 Generic Name: moxetumomab pasudotox-tdfk
Trade Name: LUMOXITI
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).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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