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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: zanubrutinib
Trade Name: BRUKINSA
Date Designated: 06/23/2016
Orphan Designation: Treatment of mantle cell lymphoma
Orphan Designation Status: Designated/Approved
BeiGene USA, Inc.
2955 Campus Drive
Suite 200
San Mateo, California 94403
United States

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

Marketing approved:

1 Generic Name: zanubrutinib
Trade Name: BRUKINSA
Marketing Approval Date: 11/14/2019
Approved Labeled Indication: BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Exclusivity End Date: 11/14/2026 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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