Search Orphan Drug Designations and Approvals
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| Generic Name: | migalastat hydrochloride | ||||||||||||||||
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| Trade Name: | GALAFOLD | ||||||||||||||||
| Date Designated: | 02/25/2004 | ||||||||||||||||
| Orphan Designation: | Treatment of Fabry Disease | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 1 | Generic Name: | migalastat hydrochloride |
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| 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 | |
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