Prescription medicine
Galsulfase Brand names: Naglazyme
Galsulfase (Naglazyme) is a prescription medicine with an FDA approval on record since 2005. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the galsulfase FDA label on DailyMed (effective September 18, 2024, BioMarin Pharmaceutical Inc.); the BLA 125117 record on Drugs@FDA; every galsulfase label on DailyMed.
Highlights of the record
FDA label of September 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate NAGLAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue NAGLAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate NAGLAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageNAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).
Forms and strengths
- 5 mg/5ml
Solution.
On the market
- Earliest approval on file
- May 31, 2005 Naglazyme, Biomarin; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,826 through July 30, 2026
What is galsulfase used for?
From the label: indications and usageNAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.
FDA pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme.
Source: FDA drug label (NAGLAZYME), BioMarin Pharmaceutical Inc., effective September 18, 2024 (SPL set 59341250-deac-ed71-3823-a4f5d64dbd77), via openFDA; the full label on DailyMed
Is there a generic for galsulfase (Naglazyme)?
No generic galsulfase is approved (Drugs@FDA, October 8, 2026).
- 2005 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the galsulfase label say about other medicines?
The galsulfase label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | boxed warning | … anaphylaxis) occurs, discontinue NAGLAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. |
Source: FDA drug label (NAGLAZYME), BioMarin Pharmaceutical Inc., effective September 18, 2024 (SPL set 59341250-deac-ed71-3823-a4f5d64dbd77), via openFDA; the full label on DailyMed
What do FAERS reports show for galsulfase?
The FDA Adverse Event Reporting System holds 3,826 reports that list galsulfase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 348 are coded as a death and 1,414 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal glycosaminoglycan-specific enzymes
- the pharmacologic class, with prices and generics
- Galsulfase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other