FDA pulls emergency use authorization for hydroxychloroquine, chloroquine for COVID-19

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FDA pulls emergency use authorization for hydroxychloroquine, chloroquine for COVID-19

By Sandra Levy - 06/15/2020

The Food and Drug Administration announced on Monday that it has revoked the emergency use authorization to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible.

The FDA said that its determination is based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery.

“This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, we determined that the legal criteria for the EUA are no longer met,” FDA said.

For more information, click here.