The United States Adopted Names (USAN) Council is a committee of the American Medical Association (AMA) that assigns nonproprietary names to drugs. The USAN Council is responsible for assigning a unique, nonproprietary name to each pharmaceutical product that is approved for sale in the United States. For example, the USAN Council assigned the nonproprietary name “atorvastatin” to the cholesterol-lowering drug Lipitor.

United States Adopted Name

Unique non-proprietary names assigned to pharmaceutical products marketed in the United States

AN Adopted name in the United States (USAN) is a unique non-proprietary name assigned to a medicine marketed in U.S. Each name is assigned by the USAN Board, which is co-sponsored by the American Medical Association (Master United States Pharmacopoeia Convention (USP) and the American Association of Pharmacists (APhA).

The USAN Program states that its purpose is to select simple, informative, and unique non-proprietary names (also called generic names) for drugs by establishing logical naming classifications based on pharmacological or chemical relationships. In addition to drugs, the USAN Board appoints agents for gene therapy and cell therapy, contact lens polymerssurgical materials, diagnostics, vehicles and substances used as excipient. The USAN Board works closely with the World Health Organization (WHO) international non-proprietary name (DCI) Committee of Experts and National Nomenclature Groups to Standardize drug nomenclature and establish rules governing the classification of new substances.

History

The USAN Council began in June 1961 after the AMA and USP jointly formed the AMA-USP Nomenclature Committee. The American Pharmacists Association (APhA) became the third sponsoring organization in 1964, when the name of the committee was changed to the USAN Council, and the United States Adopted Name became the official term to describe any negotiated and formally adopted non-proprietary name. by the Council. In 1967, a liaison representative from the Food and Drug Administration (FDA) has been appointed to serve on the USAN Board. The FDA announced in 1984 that it would stop adding drug names to its official list and would use USAN as the established name for labeling and advertising new single entity drugs. drugs marketed in the United States. The AMA Drug Council no longer exists as a separate entity. The FDA now has a representative on the USAN Board, which has moved away from chemically derived names.

Currently, the USAN Board has five members, one from each sponsoring organization, one from the FDA, and one member at large. One member is appointed to the USAN Council annually by each sponsoring organization; the FDA appoints a liaison member annually. The general member is selected by the sponsoring organizations from a list of candidates proposed by the AMA, APhA and USP. The five nominees to the Board must be approved annually by the board of trustees of the three sponsoring organizations.

USAN Board Members

Peter RheinsteinPresident of the USAN Board, since 2012

  • Gerry McEvoy, Pharm.D. (General Member)
  • Thomas P Reinders
  • David Lewis
  • Peter RheinsteinChair (since 2012)
  • Armen Melikian

Use

By definition, non-proprietary names are not subject to trade mark rights, but are entirely in the public domain. This distinguishes them from trademarked names that have been registered for private use.

naming

The assignment of a USAN takes into account practical considerations, such as the existence of trademarksthe international harmonization of drug nomenclature, the development of new drug classes and the fact that the intended uses of substances for which names are being selected may change.

The USANs assigned today reflect current naming practices and the older methods used to name drug entities. The initial nomenclature of drugs was based on the chemical structure. As newer drugs have become chemically more complex and numerous, chemically based non-proprietary names have become long and difficult to spell, pronounce, or remember. Furthermore, chemically derived names provided little useful information for non-chemistry healthcare professionals. Considering the needs of healthcare professionals has led to a system where USANs reflect the relationships between new entities and older drugs, avoiding names that might suggest nonexistent relationships.

Current naming practices involve the adoption of standardized syllables called “roots” that relate new chemical entities to existing drug families. The rods can be prefixes, suffixesor infixes in the non-proprietary name. Each stem can emphasize a certain chemical structure type, a pharmacological property, or a combination of these attributes. The recommended list of USAN rods is regularly updated to keep pace with accommodating medications with new chemical and pharmacological properties.

As a general rule, the USAN application must be submitted to the USAN Board after the New drug under investigation (IND) is active and clinical trials started.

Many drug manufacturers seeking a USAN are multinational companies with subsidiaries in various parts of the world or contractual agreements with pharmaceutical companies outside the U.S. Therefore, it is highly desirable that the pharmaceutical company, the various naming committees, and the medical community at large that a global name be established for each new single-entity compound introduced. Assigning a USAN and standardizing names internationally can take anywhere from several months to a few years.

Differences between USAN and INN

Examples of drugs for which the USAN differs from the INN include:

INN USAN
glibenclamide glyburide
isoprenaline isoproterenol
moracizine moricizine
orciprenaline metaproterenol
paracetamol paracetamol
pethidine meperidine
rifampicin rifampicin
salbutamol albuterol
torasemide torsemide
retigabine ezogabine

See too

References

External Links


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