ARIKAYCE

Insmed Incorporated🇺🇸 United States

FDA Page

Effective Date: Jun 29, 2026
Approval ID: 499ab990-2b21-474f-aaba-d86388965f40
Products: 1 registered
Version: 16

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ARIKAYCE safely and effectively. See full prescribing information for ARIKAYCE. ARIKAYCE (amikacin liposome inhalation suspension), for oral inhalation use Initial U.S. Approval: 2018 LIMITED POPULATION

Quick Stats

Total Products1

Labelers2

Label Sections21

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.