Names Adopted in the United States are unique nonproprietary names assigned to market drugs in the United States. Each name is commissioned by the USAN Council, co-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacist Association (APhA).
The USAN Program states that the aim is to choose a simple, informative, and unique nonproprietary name (also called generic name) for drugs by specifying the classification of logical nomenclature based on pharmacological or chemical relationships. In addition to drugs, the names of USAN agents for gene therapy and cell therapy, contact lens polymers, surgical materials, diagnostics, carriers, and substances used as excipients. The USAN Council works in conjunction with the International Organization of Non-Human Rights Experts (INN) of the World Health Organization (WHO) and the national nomenclature group to standardize drug nomenclature and establish rules governing the classification of new substances.
Video United States Adopted Name
Histori
The USAN Council began in June 1961 after the AMA and USP jointly established the AMA-USP Nomenclature Committee. The American Pharmacist Association (APhA) became the third sponsoring organization in 1964, where the name of the committee was changed to USAN Council, and the United States adopted name became the official term to describe the non-personal name negotiated and adopted by the Council. In 1967, a liaison representative from the Food and Drug Administration (FDA) was appointed to serve at the USAN Council. The FDA announced in 1984 that they would stop adding the name of the drug to its official list and use USAN as the name set for labeling and advertising of new single entity drugs marketed in the United States. The AMA Council on Drugs no longer exists as a separate entity. The FDA now has representation at USAN Council, which has moved from chemically derived names.
Currently, the USAN Council has five members, one from each sponsoring organization, one from the FDA, and a member-in-large. One member is nominated to the USAN Council annually by each sponsoring organization; The FDA nominates one liaison member each year. The member-in-large is selected by the sponsoring organization from the list of candidates submitted by AMA, APHA, and USP. Five nominations for the Council must be approved annually by the supervisory board of the three sponsoring organizations.
Board Member USAN
- Judith Jones
- Thomas P. Reinders
- David Lewis
- Peter Rheinstein, Chairman (since 2012)
- Armen Melikian
Maps United States Adopted Name
Use
By definition, nonproprietary names are not subject to exclusive trademark rights but are fully within the public domain. This distinguishes them from trademark names that have been registered for personal use.
Assign name
USAN assignments consider practical considerations, such as trademark presence, international harmonization of drug nomenclature, development of new drug classes, and the fact that the use of substances intended for the chosen name may change.
USAN set today reflects current naming practices and older methods used for the name of drug entities. The initial median nomenclature is based on chemical structure. As new drugs become more chemically and more complex, chemical nonpropriet names become long and difficult to spell, pronounce or remember. In addition, chemically derived names provide little useful information for non-chemical health practitioners. Taking into account the needs of health professionals leads to systems in which USAN reflects the relationship between new entities and older drugs, and avoids names that may indicate non-existent relationships.
Current nomenclature practice involves the adoption of standard syllables called "rods" that connect new chemical entities with existing drug families. The trunk can be either prefix, suffix, or infix in nonproprietary names. Each bar can emphasize specific types of chemical structures, pharmacological properties, or a combination of these attributes. Recommended list of USAN rods [1] is updated regularly to accommodate pharmaceuticals with new chemical and pharmacological properties.
As a general rule, applications for USAN should be forwarded to USAN Council after active Investigational New Drug (IND) and clinical trials have begun.
Many drug manufacturers seeking USAN are multinational companies with subsidiaries in various parts of the world or contractual agreements with drug companies outside the United States. Therefore, it is desirable for pharmaceutical companies, nomenclature committees, and the medical community in general that global names are created for each newly introduced single entity compound. Setting the name of USAN and standardization internationally can take anywhere from months to years.
Difference between USAN and INN
Examples of different drugs with USAN from INN include:
See also
- Approved English Name
- International Nonpropriet Name
- Nomenclature of monoclonal antibodies
- Pharmacopoeia United States
References
External links
- US Adopted Name Program
Source of the article : Wikipedia
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