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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 21, 2023 · Every biologic and biosimilar has a non-proprietary (“generic”) and proprietary (“brand”) name. Similar to other medications, non-proprietary names also incorporate common stems. For example, biologics like trastuzumab and rituximab share the -mab stem. This stem means these medications are both monoclonal antibodies.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are ...
Jun 18, 2020 · The FDA recommends that moving forward, all biologics and their biosimilars share a core name with the reference product, which is the nonproprietary name under which the reference product was approved (e.g., filgrastim).
An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or an active ingredient. INNs are intended to make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors.
Aug 8, 2020 · To avoid medication selection errors while maintaining the ability to track the potential for differences in the adverse event profile, the “core name” plus “distinguishing suffix” were born. The first biosimilar approved by the FDA via the 351(k) regulatory pathway was the filgrastim product Zarxio, licensed to Sandoz in March 2015.
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Nov 25, 2016 · It assigns the active ingredient of the drug a generic name, which must be cleared and reviewed by the International Nonproprietary Name program run by the World Health Organization.
