AKYNZEO

Helsinn Therapeutics (U.S.), Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 23, 2026
Approval ID: 8e47618e-af46-4d82-94e8-1507c042252d
Products: 4 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. AKYNZEO® (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous useInitial U.S. Approval: 2018

Quick Stats

Total Products4

Labelers2

Label Sections25

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.