• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
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 Jan. 1, 2013, to the present.
-
-