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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: zuretinol acetate
Date Designated: 12/02/2010
Orphan Designation: Treatment of inherited retinal dystrophies caused by confirmed biallelic RPE65 or LRAT mutations
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Retinagenix Holdings, LLC
1900 Sunset Harbor North, Unit 902
Miami Beach, Florida 33139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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