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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tirabrutinib
Date Designated: 03/21/2023
Orphan Designation: Treatment of primary central nervous system lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ono Pharma USA, Inc
One Main Street
Suite 1050
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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