Prescription medicine

Laronidase Brand names: Aldurazyme

Laronidase (Aldurazyme) is a prescription medicine with an FDA approval on record since 2003. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the laronidase FDA label on DailyMed (effective July 22, 2026, Genzyme Corporation); the BLA 125058 record on Drugs@FDA; every laronidase label on DailyMed.

Highlights of the record

FDA label of July 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS,.

and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION See full prescribing information for complete boxed warning. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. ( 5.1 ) Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring. Appropriate respiratory support should be available during infusion. ( 5.2 ) Hypersensitivity Reactions Including Anaphylaxis Patients treated with ALDURAZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. […]

Used for

From the label: indications and usage
ALDURAZYME ® is indicated for the treatment of: adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and patients with the Scheie form of MPS I who have moderate to severe symptoms.

Forms and strengths

2.9 mg/5ml

Injection (solution) (concentrate).

On the market

Earliest approval on file: April 30, 2003 Aldurazyme, Biomarin; Drugs@FDA’s file, where older or withdrawn approvals can be missing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

What is laronidase used for?

From the label: indications and usage
ALDURAZYME ® is indicated for the treatment of: adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and patients with the Scheie form of MPS I who have moderate to severe symptoms. ALDURAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for the treatment of adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for the treatment of patients with the Scheie form of MPS I who have moderate to severe symptoms. ( 1 ) Limitations of Use: The risks and benefits of treating mildly affected patients with the Scheie form have not been established. […]

FDA pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme.

Source: FDA drug label (ALDURAZYME), BLA125058 (Biomarin), as published by Genzyme Corporation, effective July 22, 2026 (SPL set a80ac249-cae4-41f3-88bb-344088b20e60), via openFDA; the full label on DailyMed

Is there a generic for laronidase (Aldurazyme)?

No generic laronidase is approved (Drugs@FDA, October 8, 2026).

2003 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the laronidase label say about other medicines?

The laronidase 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	warnings and precautions	Exercise caution if epinephrine is being considered for use in patients with MPS I due to the increased prevalence of coronary artery disease in these patients.

Check laronidase against other medicines

What next?

Other hydrolytic lysosomal glycosaminoglycan-specific enzymes: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other