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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: recombinant human histone H1.3; recombinant human N-bis-met-histone H1.3
Date Designated: 10/20/2008
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Xenetic Biosciences Plc
London Bioscience Innovation Centre
2 Royal College Street
London
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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