Quick answers
- What is Vestronidase alfa used for?
- The FDA-approved label (Mepsevii, Ultragenyx Pharmaceutical Inc., November 18, 2025) says: “MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vestronidase alfa have a boxed warning?
- Yes. The FDA label for Mepsevii has a boxed warning (“WARNING: ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Vestronidase alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vestronidase alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Vestronidase alfa?
- 1 company lists prescription products of Vestronidase alfa in the FDA NDC Directory, including Ultragenyx Pharmaceutical Inc..
What Vestronidase alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. …
— FDA label: Mepsevii, Ultragenyx Pharmaceutical Inc., effective November 18, 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: ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Mepsevii |
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.
- Ultragenyx Pharmaceutical Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761047 MEPSEVII | Ultragenyx Pharm Inc | November 15, 2017 | 2, latest December 23, 2020 2020: Efficacy · 2019: Labeling |
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) | 1989823, 1989828 |
|---|---|
| SPL set ID of the quoted label | 925d4e21-fd98-474d-a34d-a0b3558ed750 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761047 |
| Active ingredients (FDA) | VESTRONIDASE ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mepsevii, Ultragenyx Pharmaceutical Inc., effective November 18, 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 →