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USAN Council Issues Statement on Aliskiren Fumarate Naming

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Summary

The United States Adopted Names (USAN) Council issued a statement assigning the official non-proprietary name 'aliskiren fumarate' for the drug compound. This designation provides the standardized USAN name that pharmaceutical manufacturers must use in labeling, applications, and communications. The statement was filed with the FDA as document FDA-2026-P-4112.

Published by USAN Council on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The USAN Council has assigned the official non-proprietary name 'aliskiren fumarate' through its standard naming process. This establishes the standardized name for regulatory and commercial use in the United States.

Pharmaceutical manufacturers developing or marketing products containing this compound should ensure their labeling, FDA submissions, and prescribing information reflect the USAN Council's assigned name. Drug naming assignments by the USAN Council are adopted for use across pharmaceutical labeling, compendial references, and regulatory filings.

Archived snapshot

Apr 22, 2026

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Last updated

Classification

Agency
USAN Council
Instrument
Notice
Branch
Independent
Joint with
FDA
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
FDA-2026-P-4112

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug naming Regulatory submissions
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Topics
Healthcare Intellectual Property

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