In May of 2014, the FDA issued a draft guidance entitled Best Practices in Developing Proprietary Names for Drugs. This draft guidance contained recommendations for the selection of proprietary names for both prescription (Rx) and over-the-counter (OTC) medications. In the 6-and-a-half-year interval that has passed since the issuance of this guidance, the FDA has initiated divorce proceedings for the Rx and OTC versions of the guidances. The two Federal Register (FR) notices announcing the divorce can be found here for the Rx version and here. The separation of the guidance document was based on comments received in response to the initial draft.
The Rx version (entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products) is being issued in final and can be found here (FR notice here) and the OTC version (entitled Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products) is being reissued in draft form and can be found here (FR notice here).
Both documents provide sound advice from FDA on a variety of proprietary naming issues in order to assist firms in making naming decisions that will aid in avoiding medication errors and helping firms from running afoul of misbranding issues and other potential legal troubles.
