How To Choose A Proprietary Rx Drug Name
Executive Summary
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.
You may also be interested in...
US FDA: User-Error Risks Grow When OTC Brands Extend With Different Ingredients, Indications
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.
Concerned By Confusion Over OTC Drug Brands, US FDA Offers Guidance On Developing Names
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.
Brand Name Review By FDA: Predictability Returns To Process
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.