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US FDA: User-Error Risks Grow When OTC Brands Extend With Different Ingredients, Indications

 
• By Eileen Francis

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.

Drug firms shouldn’t use terms describing a product’s format or medical abbreviations in OTC brand names but should expect some risk of consumer confusion if they extend brands to include additional ingredients or indications, says the US Food and Drug Administration.

In a draft guidance published on 8 December, the FDA diverts from a previous attempt in 2014 at...

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