SCENESSE

CLINUVEL INC.🇺🇸 United States

FDA Page

Effective Date: May 11, 2026
Approval ID: 94f53286-11dd-7fbb-e053-2a95a90a7c48
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SCENESSE safely and effectively. See full prescribing information for SCENESSE. SCENESSE® (afamelanotide) implant, for subcutaneous use. Initial U.S. Approval: 2019

Quick Stats

Total Products1

Labelers2

Label Sections29

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.