Quick answers
- What is Elosulfase alfa used for?
- The FDA-approved label (Vimizim, BioMarin Pharmaceutical Inc., October 30, 2025) says: “VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Elosulfase alfa have a boxed warning?
- Yes. The FDA label for Vimizim has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Elosulfase alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Elosulfase alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Elosulfase alfa?
- 1 company lists prescription products of Elosulfase alfa in the FDA NDC Directory, including BioMarin Pharmaceutical Inc..
What Elosulfase alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
— FDA label: Vimizim, BioMarin Pharmaceutical Inc., effective October 30, 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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Vimizim |
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.
- BioMarin 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 |
|---|---|---|---|
| BLA125460 VIMIZIM | Biomarin Pharm | February 14, 2014 | 2, latest October 30, 2025 2025: Labeling · 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) | 1490047, 1490052 |
|---|---|
| SPL set ID of the quoted label | 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125460 |
| Active ingredients (FDA) | ELOSULFASE ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vimizim, BioMarin Pharmaceutical Inc., effective October 30, 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 →