US guidance on proprietary names

Home/Guidelines | Posted 15/01/2021 post-comment0 Post your comment

The US Food and Drug Administration (FDA) issued a guidance for industry on best practices in developing proprietary names for prescription drugs, in December 2020 [1].

Naming 1 V13I27

The new guidance has been created to help sponsors of human prescription drug products develop proprietary names for those products. It outlines several best practices that will minimize proprietary name-related medication errors that can cause serious, sometimes fatal, problems. It also hopes to avoid adoption and use of names that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA uses a framework for evaluating proposed proprietary names and the guidance explains details of this. Drug product sponsors can use this prior to submitting names for FDA review. The FDA guidance outlines how it uses Phonetic and Orthographic Computer Analysis (POCA) software to evaluate proposed product names.

In general, the guidance outlines certain things that should be avoided when naming, such as similarities in spelling or pronunciation, listing inert of inactive ingredients as co-equal with active ingredients, and the omission of active ingredient(s) when two or more are present. For reference, it also includes high- and low-similarity name pair lists and a checklist for moderately similar name pairs.

In addition, FDA has issued a separate draft guidance for industry on best practices in developing proprietary names for non-prescription drugs [2]. Both guidance documents also recommend against incorporating the sponsor’s name in a proprietary name.

It is noted that the new guidance (and draft guidance) does not address the designation of established names or proper names.

Related articles
Guidelines released on USAN naming

Distinct suffixes will aid biosimilar competition says new research

Stakeholders question FDA’s guidance on naming biologicals

FDA proposes update to biosimilar naming guideline

US guidelines for biosimilars

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

 

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

References
1. U.S. Food and Drug Administration. Best practices in developing proprietary names for human prescription drug products. Guidance for industry. December 2020 [homepage on the Internet]. [cited 2021 Jan 15]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-developing-proprietary-names-human-prescription-drug-products-guidance-industry
2. U.S. Food and Drug Administration. Best practices in developing proprietary names human nonprescription drug products. Draft guidance for industry. December 2020 [homepage on the Internet]. [cited 2021 Jan 15]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-developing-proprietary-names-human-nonprescription-drug-products-draft-guidance

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Mexico introduces new decree on health regulation
Regulation-V13H16
Home/Guidelines Posted 27/08/2021
Draft decree for prescribing generics in Costa Rica
46 MD001580
Home/Guidelines Posted 09/07/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010