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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: IgG4 Fc linked recombinant human AAT (alpha-1 antitrypsin)
Date Designated: 03/02/2022
Orphan Designation: Treatment of Congenital Alpha-1 Antitrypsin Deficiency (AATD)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi AATD Inc.
450 Water Street
Cambridge, Massachusetts 01241
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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