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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: small molecule inhibitor of histone methyltransferase DOT1L
Date Designated: 08/15/2013
Orphan Designation: Treatment of Acute Myeloid Leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Epizyme Inc.
400 Technology Square, 4th Floor
Cambridge, Massachusetts 02139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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