VIMIZIM (ELOSULFASE ALFA)
Summary
FDA approved VIMIZIM (ELOSULFASE ALFA) by BIOMARIN PHARM. BLA (Biologic) approval (Labeling) on 2025-10-30. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA125460-25
Action Date
2025-10-30
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
VIMIZIM (generic: ELOSULFASE ALFA), INJECTABLE, INJECTION. Application: BLA125460
Company
Context & Analysis
BIOMARIN PHARM has 3 FDA actions in our database.
Frequently Asked Questions
How often does BIOMARIN PHARM have FDA actions?
BIOMARIN PHARM has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA125460-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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