← FDA Drug Approvals (Drugs@FDA)

ELFABRIO

BLA · Biologics License Application · Sponsor: CHIESI FARMACEUTICI SPA · Approved 2023-05-09

Drug application

FDA Application #

BLA761161

Application type

Biologics License Application

Brand name

ELFABRIO

Generic name

PEGUNIGALSIDASE ALFA

Active ingredients

PEGUNIGALSIDASE ALFA-IWXJ

Dosage form

VIAL

Route

SINGLE-USE

Marketing status

Prescription

Sponsor

CHIESI FARMACEUTICI SPA

Manufacturer

Chiesi USA, Inc.

First approval

2023-05-09

Source

Authoritative

Drugs@FDA application overview

Machine

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