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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Synthetic derivative of 16-hydroxy-9Z, 12Z, 14E-octadecatrienoic acid
Date Designated: 10/24/1991
Orphan Designation: Prophylactic treatment of sickle cell disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Omex International, Inc.
6001 Savoy, Suite 110
Houston, Texas 77036
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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