# PONLIMSI
> **BLA761385** · Biologics License Application · Sponsor: TEVA PHARMACEUTICALS, INC. · Approved 2026-03-27
## Drug
- **FDA Application Number:** BLA761385
- **Application type:** Biologics License Application
- **Brand name:** PONLIMSI
- **Generic name:** Denosumab-Adet
- **Active ingredients:** DENOSUMAB-ADET
- **Dosage form:** INJECTABLE
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** TEVA PHARMACEUTICALS, INC.
- **First approval:** 2026-03-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761385)
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