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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 6-(4-((1s,3s)-1-amino-3-hydroxycyclobutyl) phenyl)-1-ethyl-7- phenyl-1H-pyrido[2,3-b][1,4]oxazin-2(3H)-one L-Tartrate salt
Date Designated: 12/07/2022
Orphan Designation: Treatment of Hereditary Hemorrhagic Telangiectasia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Vaderis Therapeutics AG
Lichtstasse 35
Building WSJ-350
Basel, Basel CH-4056
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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