How To Choose A Proprietary Rx Drug Name
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
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US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.
Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.
CDER now granting 86% of sponsors’ preferred proprietary names prior to launch – a significant improvement over just five years ago that seems driven in part by several new guidance documents.