USA – FDA revokes EUA for hydroxychloroquine, chloroquine

The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) allowing the use of chloroquine phosphate and hydroxychloroquine sulfate to treat hospitalized patients with coronavirus disease (COVID-19) at the request of the Biomedical Advanced Research and Development Authority (BARDA).
“Today’s request to revoke is 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 and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” FDA writes in its letter revoking the EUA, which was first issued in late March.
FDA’s decision to issue the EUA for hydroxychloroquine and chloroquine was controversial, prompting questions about the agency’s standards and political independence, and much of the public debate over the use of the drugs was highly politically charged. (RELATED: Harvard professors call on FDA to maintain review standards amid COVID-19Regulatory Focus 15 April 2020)…