This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission.

Accurate identification of medications is critical to preventing medication errors and potential harm to the public. This guidance is intended to assist industry in the submission of a complete package of information that FDA will use in the assessment of:

1. the safety aspects of a proposed proprietary name, to reduce medication errors, and

2. the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using our traditional review methods.

This guidance applies to proprietary name submissions for the following types of products:

• prescription drug products, including biologics, that are the subject of an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA)

• nonprescription drug products that are the subject of an IND, NDA, or ANDA

This guidance does not describe the methods used for evaluation of proposed proprietary names using the traditional review process, nor does the guidance describe the information needed by FDA to evaluate proposed proprietary names under the voluntary 2-year pilot program being conducted by CDER and CBER. That information can be found in the FDA concept paper entitled “PDUFA Pilot Project Proprietary Name Review,” dated September 2008.

Posted on the FDA website on 5 April 2016