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In addition, FDA has issued a separate draft guidance for industry on best practices in developing proprietary names for non-prescription drugs [2].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It is noted that the new guidance (and draft guidance) does not address the designation of established names or proper names.

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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 Draft guidance for industry.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

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