Quick answers
- What is Agalsidase beta used for?
- The FDA-approved label (Fabrazyme, Genzyme Corporation, August 22, 2025) says: “FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Agalsidase beta have a boxed warning?
- Yes. The FDA label for Fabrazyme has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Agalsidase beta?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Agalsidase beta been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Agalsidase beta?
- 1 company lists prescription products of Agalsidase beta in the FDA NDC Directory, including Genzyme Corporation.
What Agalsidase beta is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
— FDA label: Fabrazyme, Genzyme Corporation, effective August 22, 2025. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Fabrazyme |
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.
- Genzyme Corporation2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103979 FABRAZYME | Genzyme | April 24, 2003 | 10, latest July 10, 2024 2024: Labeling · 2024: Labeling · 2021: Efficacy |
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
| RxCUI (RxNorm) | 1804755, 1804758, 1804760, 1804762 |
|---|---|
| SPL set ID of the quoted label | 988513ab-b06f-4dd0-93f7-d2d4531dcce4 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA103979 |
| Active ingredients (FDA) | AGALSIDASE BETA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fabrazyme, Genzyme Corporation, effective August 22, 2025; 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 →