BENLYSTA

GlaxoSmithKline LLC🇺🇸 United States

FDA Page

Effective Date: Aug 21, 2026
Approval ID: 2fa3c528-1777-4628-8a55-a69dae2381a3
Products: 3 registered
Version: 38

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BENLYSTA safely and effectively. See full prescribing information for BENLYSTA. BENLYSTA (belimumab) for injection, for intravenous useBENLYSTA (belimumab) injection, for subcutaneous useInitial U.S. Approval: 2011

Quick Stats

Total Products3

Labelers2

Label Sections41

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.