FDA revokes EUA for Hydroxychloroquine to treat Coronavirus

It was announced on June 15th that the US Food and Drug Adminsitration (FDA) had revoked the Emergency Use Autorisation of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19. 

A request was submitted to the FDA by BARDA stating that they were requesting to revoke the use of these drugs "based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks"

Upon review of the data, and regulations the FDA also concluded that "it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks. Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19, pursuant to section 564(g)(2) of the Act. As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19."

The full letter outling the revocation can be viewed here

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