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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  A recombinant adeno-associated viral (AAV) vector encoding the human otoferlin (hOTOF) gene.
Date Designated:  04/12/2021
Orphan Designation:  Treatment of otoferlin gene (OTOF)-mediated hearing loss
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Akouos, Inc.
645 Summer Street
Suite 200
Boston, Massachusetts 02210
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.