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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (S)-4,5-dihydro-2[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiaxolecarboxylic acid
Date Designated: 02/04/2009
Orphan Designation: Treatment of chronic iron overload in patients with transfusion-dependent anemias
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/20/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shire Development LLC
300 Shire Way
Lexington, Massachusetts 02421
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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