United States Adopted Names
It is the policy of the USAN Program that firms should apply for a non-proprietary drug name through their national nomenclature program first. In the United States of America this national agency is the USAN Program.
In addition to being policy, there are benefits associated with applying for a USAN before an INN.
Benefits of Applying for a USAN First:
1) Clearance by the USAN Council (USANC) before the name is submitted to the INN Experts.
2) USAN staff files the INN application on your behalf. We have done hundreds of INN applications, and we are very experienced and know all the ins and outs of this process. Additionally, we know how to present the case for a specific name, to which the USANC has agreed, having done this so many times before.
3) Less time to an adopted USAN; USANs are adopted after the INN meeting and before the name appears on a proposed INN published list.
4) Assistance from USAN staff in coming up with suitable prefixes and name alternatives.
5) Accessibility/consultations with staff for applicants on stem choices.
6) Continuous balloting throughout the year. USANC review is not limited to biannual meetings.
USAN Program and Biosimilar Nomenclature:Biosimilar Nomenclature Policy
New Rules for Monoclonal Antibody Nomenclature:Monoclonal Antibody Rules
Policy Change: Due to an increase in third party (non-applicant) requests for stem determinations and the resulting increased demand of USAN staff time, the USAN Program will no longer provide potential stem reviews for third party non-proprietary naming consultants who bill their clients for "USAN staff provided" information. USAN Program staff will continue to help and advise USAN applicants directly.
Newly Revised USAN Stem List: USAN stems
Important Note to Manufacturers: Upon receipt of the adoption notice letter and adoption statement from USAN, the manufacturer has 60 days to review the adoption statement for accuracy, initial, and return back to the USAN office. After the 60 days has expired, with or without an initialed adoption statement, the manufacturer’s adopted USAN will be scheduled for publishing on the USAN website after the 1st of the following month. Any changes, edits, or modifications made on the manufacturer’s behalf after the 60 day period will result in a Revision/Modification Fee of $3,000. After Nov.1, 2013 the new Revision/Modification Fee increases to $5,000.
The purpose of the United States Adopted Names Council (USANC) is to serve the health professions in the United States by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.
The USANC is tri-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA). In addition, the Food and Drug Administration (FDA) cooperates with and is represented on the USANC. The USANC aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously. The USANC works closely with the International Nonproprietary Name (INN) Program of the World Health Organization (WHO), and various national nomenclature groups.
A listing of adopted USAN.
USAN application process: how to apply for a name
Considerations and requirements before, during and after a name is recommended and adopted.
Names under consideration
A listing of names under consideration by the USAN Council.
Guidelines for assigning USAN for biological products such as insulins, interferons, interleukins, growth hormones, colony-stimulating factors, cytokines, monoclonal antibodies, and coagulation factors.
In 2012, new application requirements have been established for biologics. Please review these requirements and include with your application materials.
This section describes how to apply for a USAN for a contact lens material.
Gene therapy naming scheme
Gene therapy naming scheme to assign names to non-cellular products. This scheme distinguishes a gene therapy drug and conveys safety information to the user physician.
Immunotherapy naming schemes
The nomenclature schemes for immunotherapy products, described in this report, were developed by the USAN working group for immunotherapies. The naming schemes would apply to all immunotherapy products, with the exception of minimally manipulated hematopoietic elements, combination products and prophylactic vaccines.
Organic radicals, counterions and solvent molecules used in coining two-word names
Listing which includes terms for common and uncommon radicals and anions compiled by USAN for the purpose of providing assistance and guidance in selecting appropriate two-word names when working with salts and esters.
Geometric isomerism and chirality: the USAN perspective
This document explores the "USAN experience" with substances that have a chiral center and explains nomenclature rules for enantiomers and stereoisomers. We analyzed records of USAN adoptions between 1999 and 2004 to see how many chiral compounds were undergoing clinical development.