# ELFABRIO
> **BLA761161** · Biologics License Application · Sponsor: CHIESI FARMACEUTICI SPA · Approved 2023-05-09
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761161)
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