03-30-2020, 11:28 PM
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#479 (permalink)
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https://www.fda.gov/media/136534/download
Quote:
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19, when used consistently with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.
Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I of this letter, I have concluded that chloroquine phosphate and hydroxychloroquine sulfate (as described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.
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