WEZLANA

Nuvaila Limited🇺🇸 United States

FDA Page

Effective Date: Jun 3, 2026
Approval ID: a6c23978-09f0-4796-88f7-d0ce7e3ed04e
Products: 7 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use WEZLANA safely and effectively. See full prescribing information for WEZLANA. WEZLANA (ustekinumab-auub) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2023 WEZLANA (ustekinumab-auub) is biosimilar to STELARA (ustekinumab).

Quick Stats

Total Products7

Labelers1

Label Sections20

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.