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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sodium dichloroacetate
Date Designated: 06/11/1990
Orphan Designation: Treatment of congenital lactic acidosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Saol Therapeutics Inc.
Ground Floor, 9 Windsor Place
Dublin 2 D02 YF30
Ireland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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