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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 nonreplicating adeno-associated virus, serotype SAN011 that expresses an artificial microRNA
Date Designated: 07/10/2024
Orphan Designation: treatment of myotonic dystrophy type 1
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi US Services Inc.
100 Morris Street
Morristown, New Jersey 07960
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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