USAN Council Issues Statement on Aliskiren Fumarate Naming
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.
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, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Mentioned entities
Related changes
Get daily alerts for Regs.gov: Food and Drug Administration
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from USAN Council.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when Regs.gov: Food and Drug Administration publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.