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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride
Date Designated: 01/12/2011
Orphan Designation: Treatment of acute myeloid leukemia (AML).
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/15/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
EMD Serono, Inc.
One Technology Place
Rockland, Massachusetts 02370
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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