FDA publishes draft guidance on evaluation of proprietary names

The US Food and Drug Administration has published a draft guidance document on the contents of a complete submission for the evaluation of proprietary names. The agency's move is part of its new performance goals under the terms of the Prescription Drug User Fee Act's renewal last year (Marketletters passim). The primary concern of the FDA for proprietary names for prescription and over-the-counter medicines is safety, supported by research from the Institute of Medicine in 2006 which highlighted the danger of agents having similar spelling or sounding names (Marketletters passim).

The FDA Law Blog reports that submissions for products that have proposed labels and labeling should include such details as the appearance and visibility of critical information, eg, if it is similar to a different drug or dosage.