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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 adeno-associated virus vector expressing the cyclic nucleotide gated channel alpha subunit (CNGA3)
Date Designated: 11/16/2015
Orphan Designation: Treatment of achromatopsia caused by mutations in the CNGA3 gene
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Beacon Therapeutics
14193 NW 119th Terrace
Suite 10
Alachua, Florida 32615
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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