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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tafasitamab
Trade Name: MONJUVI
Date Designated: 12/01/2014
Orphan Designation: Treatment of diffuse large B-cell lymphoma
Orphan Designation Status: Designated/Approved
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tafasitamab
Trade Name: MONJUVI
Marketing Approval Date: 07/31/2020
Approved Labeled Indication: MONJUVI® is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
Exclusivity End Date: 07/31/2027 
Exclusivity Protected Indication* :  indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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