ELFABRIO (PEGUNIGALSIDASE ALFA)
Summary
FDA approved ELFABRIO (PEGUNIGALSIDASE ALFA) by CHIESI FARMACEUTICI SPA. BLA (Biologic) approval (Type 1 - New Molecular Entity) on 2023-05-09. VIAL, SINGLE-USE.
Details
Source
Drug Approval
External ID
BLA761161-1
Action Date
2023-05-09
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
ELFABRIO (generic: PEGUNIGALSIDASE ALFA), VIAL, SINGLE-USE. Application: BLA761161
Company
Context & Analysis
CHIESI FARMACEUTICI SPA has 2 FDA actions in our database.
Frequently Asked Questions
How often does CHIESI FARMACEUTICI SPA have FDA actions?
CHIESI FARMACEUTICI SPA has 2 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 "BLA761161-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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