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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-[(6S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thienol[3,2,-f]-[1,2,4]triazolo[4,3-a][1,4]diazepin-6-yl]-N-(4-hydroxyphenyl)-acetamide dihydrate
Date Designated: 07/16/2014
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/17/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
OncoEthix GmbH (Merck Subsidiary)
Weystrasse 20
Lucerne
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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