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Mar 25, 2024 · The non-proprietary name of a drug is the name accepted by a competent scientific body or authority, such as the USAN or BAN. The non-proprietary names of newer drugs are kept uniform by an agreement to use the Recommended International Nonproprietary Name (rINN) in all member countries of the World Health Organization (WHO).
Feb 2, 2021 · FDA Government Agencies. By Thomas Sullivan Last updated Jan 24, 2021. The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs.
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Mar 8, 2016 · respects in which the drug differs. See FDCA 501(b) and 502(e)(3)(b), and the Food and Drug Administration (FDA) regulations at 21 CFR 299.5. The FDCA requires all drugs to have an “established name,” which is a nonproprietary name, other than the applicable systematic chemical name. The established name is almost always tied to the drug ...
Jun 6, 2020 · Drugs often have several names. A marketed drug may have up to four different types of names: a chemical name, a company name, a generic name, and a brand name. • Chemical name: When a drug is first discovered, it is given a chemical name. This describes the atomic or molecular structure of the drug. The chemical name is thus usually too complex and cumbersome for general use and is almost ...
Apr 13, 2021 · The World Health Organization assigns international nonproprietary names (INN), also known as common names, to compounds upon request from drug developers. Structures of INNs are publicly available and represent a source, albeit underused, to understand trends in drug research and development.
- Marta Serafini, Sarah Cargnin, Alberto Massarotti, Gian Cesare Tron, Tracey Pirali, Armando A Genazz...
- 2021
Mar 2, 2015 · Nomenclature (names) Any drug may have names in all three of the following classes: 1. The full chemical name. 2. A non-proprietary (official, approved, generic) name used in pharmacopoeias and chosen by official bodies; the World Health Organization (WHO) chooses recommended International Non-proprietary Names (rINNs).
A non-proprietary name of a drug, after its regulatory approval, is the accepted name by a competent scientific body/authority e.g. British Approved Name (BAN), Japanese Accepted Name (JAN) and United States Adopted Name (USAN) etc. [3,4].
