# OTULFI
> **BLA761379** · Biologics License Application · Sponsor: FRESENIUS KABI USA · Approved 2025-04-30
## Drug
- **FDA Application Number:** BLA761379
- **Application type:** Biologics License Application
- **Brand name:** OTULFI
- **Generic name:** USTEKINUMAB-AAUZ
- **Active ingredients:** USTEKINUMAB-AAUZ
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** FRESENIUS KABI USA
- **Manufacturer:** Fresenius Kabi USA, LLC
- **First approval:** 2025-04-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761379)
---
*MORVS · CC0 1.0*