Sunlenca

Gilead Sciences🇺🇸 United States

FDA Page

Effective Date: Aug 27, 2026
Approval ID: e5652804-29c4-40d7-aeb2-0142ed2a7b5b
Products: 3 registered
Version: 14

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SUNLENCA safely and effectively. See full prescribing information for SUNLENCA. SUNLENCA (lenacapavir) tablets, for oral use SUNLENCA (lenacapavir) injection, for subcutaneous use Initial U.S. Approval: 2022

Quick Stats

Total Products3

Labelers3

Label Sections42

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.