Quick answers
- What is Miglustat used for?
- The FDA-approved label (Zavesca, Actelion Pharmaceuticals US, Inc., April 20, 2023) says: “ZAVESCA is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Miglustat have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Miglustat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Miglustat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Miglustat?
- 7 companies list prescription products of Miglustat in the FDA NDC Directory, including Edenbridge Pharmaceuticals LLC., Actelion Pharmaceuticals US, Inc. and CoTherix, Inc..
What Miglustat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZAVESCA is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. …
— FDA label: Zavesca, Actelion Pharmaceuticals US, Inc., effective April 20, 2023. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Edenbridge Pharmaceuticals LLC.1 product
- Actelion Pharmaceuticals US, Inc.1 product
- CoTherix, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Amicus Therapeutics US, LLC1 product
- Navinta LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021348 ZAVESCA | Actelion | July 31, 2003 | 7, latest December 8, 2020 2020: Labeling · 2019: Labeling · 2016: Manufacturing (CMC) |
| NDA215211 OPFOLDA | Amicus Therap Us | September 28, 2023 | 1, latest July 25, 2024 2024: Labeling |
Generic approvals (3)
- ANDA208342Ani Pharms · April 17, 2018
- ANDA209821Edenbridge Pharms · August 6, 2020
- ANDA219111Navinta LLC · March 14, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zavesca, Actelion Pharmaceuticals US, Inc., effective April 20, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →