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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (2S,3S,4E,6S,7R,10R)-7,10-Dihydroxy-3,7-dimethyl-12-oxo-2-[(2E,4E,6R)-6-(pyridin-2-yl)hepta-2,4-dien-2-yl]oxacyclododec-4-en-6-yl 4-methylpiperazine-1-carboxylate
Date Designated: 06/21/2017
Orphan Designation: Treatment of acute myeloid leukemia (AML)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 12/06/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Eisai Inc.
200 Metro Boulevard
Nutley, New Jersey 07110
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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