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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: migalastat hydrochloride
Trade Name: GALAFOLD
Date Designated: 02/25/2004
Orphan Designation: Treatment of Fabry Disease
Orphan Designation Status: Designated/Approved
Amicus Therapeutics, Inc.
1 Cedarbrook Drive
Cranbury, New Jersey 08512
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: migalastat hydrochloride
Trade Name: GALAFOLD
Marketing Approval Date: 08/10/2018
Approved Labeled Indication: GALAFOLD¿ is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
Exclusivity End Date: 08/10/2025 
Exclusivity Protected Indication* :  GALAFOLD¿ is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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