FDA & Proprietary Names

FDA has published a draft document on “Best Practices in Developing Proprietary Names for Drugs”.

This document is intended to help companies develop product names that do not cause or contribute to medication errorsor otherwise contribute to the misbranding of the drug. With safety in mind, it describes design practices to help avoid such errors with proprietary names and provides a qualitative systematic framework for evaluating proposed proprietary names. This guidance applies to all prescription and OTC drug products.

(This guidance does not address the selection of established names or proper names.)

This document is available for download at