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These highlights do not include all the information needed to use GALAFOLD safely and effectively. See full prescribing information for GALAFOLD. GALAFOLD® (migalastat) capsules, for oral use Initial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1)]. This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- generic_name
- migalastat hydrochloride
- product_names
- migalastat hydrochloride
- ndc
- 71904-100, 71904-100-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en