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A United States Adopted Name (USAN) is a nonproprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names. These principles take into account the existence of trademarks, international harmonization of drug nomenclature, new classes of drugs and the fact that the intended uses of substances for ...
a monograph containing a nonproprietary name in the title that differs from that in the FDA license (e.g. a BLA proper¶ name), it is possible. ±Congress did give FDA authority to specify a USP official title/name; but it cannot be done in an NDA or BLA ± the only way to override USP is by using notice and comment rulemaking. FDCA 508
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More than 50 years ago, WHO established the International Nonproprietary Name (INN) Expert Group/WHO Expert Committee on Specifications for Pharmaceutical Preparations, to assign nonproprietary names (INN) to medicinal substances, so that each substance would be recognized globally by a unique name.
INN abbreviation Latin INN abbreviation English structure erbuminum erbumine 2-methylpropan-2-amine olaminum olamine 2-aminoethanol 10. In the INNM for a salt, in the case when INN for an acid is a two-word name containing the word "acid", an element describing acid component is formed from the name of the acid in the way described in para. 8.
acknowledged as an extraordinary approved variant vaccine INN, available for use by the applicant in an expedited manner. The fee for a request of an INN for a variant COVID-19 vaccine active substance where a previous INN has been assigned to the original vaccine substance will no longer be waived. Standard fees will
consideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a name in the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substance in medicine or pharmacy. Lists of Proposed (1–85) and Recommended (1–45) International Nonproprietary ...
