---
brand_name: "FABRAZYME"
generic_name: "AGALSIDASE BETA"
slug: "agalsidase-beta-ravenous-35mg-vial"
canonical_url: "https://medichelpline.com/drug-index/agalsidase-beta-ravenous-35mg-vial"
content_type: "drug_monograph"
route: "INTRAVENOUS"
drug_class: "General Medications"
fda_updated_at: "2024-07-10T00:00:00.000Z"
license: "Drugs@FDA Public Domain / Informational Use"
---
# FABRAZYME (AGALSIDASE BETA)
## Clinical Monograph Metadata
- **Canonical URL:** https://medichelpline.com/drug-index/agalsidase-beta-ravenous-35mg-vial
- **Generic / Active Ingredient:** AGALSIDASE BETA
- **Brand Name:** FABRAZYME
- **Administration Route:** INTRAVENOUS
- **Pharmacological Class:** General Medications
- **FDA Data Timestamp:** 2024-07-10T00:00:00.000Z
## Primary Indication & Clinical Use
Review priority: STANDARD Marketing status: Prescription
## Monograph Summary

Approval overview FABRAZYME is listed in Drugs@FDA under application 103979 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient AGALSIDASE BETA Form and strength VIAL; INTRAVENOUS - 35MG/VIAL Sponsor GENZYME Submission history Latest submission status date: 2024-07-10 00:00:00. Submission type: SUPPL.

## Primary Sources & FDA Regulatory Records
- [Drugs@FDA Primary Database](https://www.accessdata.fda.gov/scripts/cder/daf/) (Reference Slug: `agalsidase-beta-ravenous-35mg-vial`)
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