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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Non-replicating recombinant adeno-associated virus serotype 1 vector delivering human GRN gene encoding the protein progranulin
Date Designated: 01/07/2021
Orphan Designation: Treatment of frontotemporal dementia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Passage Bio, Inc.
Commerce Square Two
2001 Market Street
Philadelphia, Pennsylvania 19103
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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