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.

Post-market surveillance of medication errors showing that consumers confuse nonprescription drug brands with Rx drugs has prompted a draft guidance from the US Food and Drug Administration on developing OTC brand names.

The document, made available along with a separate draft guidance on naming Rx drugs, is intended “to help ensure that...