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FDA Withdraws Emergency Use Authorization For Hydroxychloroquine

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FDA Withdraws Emergency Use Authorization For Hydroxychloroquine

The United States Food and Drug Administration on Monday withdrew the emergency use authorization it granted for hydroxychloroquine and chloroquine sulfates against the COVID-19 coronavirus.

The federal agency had granted the EUA for the antimalarial drugs in late March based on preliminary studies suggesting effectiveness against developing severe symptoms from COVID-19, with its known and potential benefits outweighing any risk involved.

"FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA," the regulatory body said.

"Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use."

FDA added that the use of the two drugs could "decrease the effectiveness of other potential COVID-19 treatments," including Gilead Inc.'s (NASDAQ: GILD) Remdesivir.

The federal agency said the clinical trials for the effectiveness of the antimalarial drugs against COVID-19 are continuing.

 

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