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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 3-([3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1Lambda6,2,5-benzothiadiazepin-8-yl]oxy)propanoic acid
Date Designated: 11/15/2022
Orphan Designation: Treatment of Primary Sclerosing Cholangitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Albireo AB
Arvid Wallgrens backe 20
Göteborg, Göteborg 413 46
Sweden

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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