Skytrofa

Ascendis Pharma Endocrinology, Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 23, 2026
Approval ID: 9229f871-bc61-4ddc-8122-d126d40e36ac
Products: 14 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SKYTROFA safely and effectively. See full prescribing information for SKYTROFA. SKYTROFA (lonapegsomatropin-tcgd) for injection, for subcutaneous use Initial U.S. Approval: 2021

Quick Stats

Total Products14

Labelers2

Label Sections54

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.