APPLICATION
BLA761161
TYPE
BLA
ORIGINAL APPROVAL
2023-05-09
LATEST ACTION
2023-05-09
ROUTE
INTRAVENOUS, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription
Products
ELFABRIOPrescription
PEGUNIGALSIDASE ALFA-IWXJ 20MG/10ML · VIAL · SINGLE-USE
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.