Osenvelt

CELLTRION USA, Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 5, 2026
Approval ID: c5a5d750-80be-49cd-b4a6-c8a815956059
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OSENVELT safely and effectively. See full prescribing information for OSENVELT. OSENVELT (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 OSENVELT (denosumab-bmwo) is biosimilar to XGEVA (denosumab)

Quick Stats

Total Products1

Labelers2

Label Sections34

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.