March 30th, 2020

reasonable to believe

March 28, 2020

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I have concluded that the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19 when administered as described in the Scope of Authorization (section II) meet the criteria for issuance of an authorization under Section 564(c) of the Act, because:

1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products; and

3. There is no adequate, approved, and available alternative to the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID19.

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Denise M. Hinton
Chief Scientist
Food and Drug Administration


https://www.fda.gov/media/136534/download