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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mosunetuzumab-axgb
Trade Name: Lunsumio
Date Designated: 12/17/2018
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: mosunetuzumab-axgb
Trade Name: Lunsumio
Marketing Approval Date: 12/22/2022
Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Exclusivity End Date: 12/22/2029 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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