Treats a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (…. NDA 208623, held by Amicus Therap US. Migalastat Hydrochloride.
As of Nov 13, 2026, NDA 208623 (Galafold), held by Amicus Therap US, was first approved by FDA on Aug 10, 2018, with 7 approved supplements and 0 published complete response letters.
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. This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| GalafoldEQ 123MG BASE · capsule;oral | Migalastat Hydrochloride | RxReference drug |
| Mar 19, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Jun 5, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Jun 20, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Jun 20, 2023 | Supplement 6Labeling · Standard review | Approved | |
| Dec 10, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Sep 25, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Aug 22, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Aug 10, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
