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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
Date Designated:  07/20/2016
Orphan Designation:  Treatment of chronic lymphocytic leukemia.
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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