# ENOBY
> **BLA761439** · Biologics License Application · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2025-09-26
## Drug
- **FDA Application Number:** BLA761439
- **Application type:** Biologics License Application
- **Brand name:** ENOBY
- **Generic name:** DENOSUMAB-QBDE
- **Active ingredients:** DENOSUMAB-QBDE
- **Dosage form:** SOLUTION
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** HIKMA PHARMACEUTICALS USA INC
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2025-09-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761439)
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