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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: linerixibat
Date Designated: 09/18/2019
Orphan Designation: Treatment of Primary Biliary Cholangitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GlaxoSmithKline
1250 South Collegeville Road
Building 4, Mail Stop 4400
Collegeville, Pennsylvania 19426
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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