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Remdesivir EUA Includes Promotional Limitations Absent From Chloroquine Authorization

 
• By Sue Sutter

Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.

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In the world of FDA drug regulation, "authorized" does not equal "approved." • Source: Shutterstock

The US Food and Drug Administration’s emergency use authorization for remdesivir includes boilerplate language limiting what Gilead Sciences Inc. can say about the drug – language that was absent from the only other EUA granted for a potential COVID-19 therapeutic.

The agency issued the EUA to Gilead on 1 May, authorizing the use of remdesivir for hospitalized, severe COVID-19...

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