ABSTRACT

Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate   [open pdf - 134KB]

This document provides answers to the following questions: "Why was the Emergency Use Authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) revoked?"; "Will the revocation of the EUA impact the use of hydroxychloroquine sulfate (HCQ) or chloroquine phosphate (CQ) for their FDA-approved uses?"; "What if I am in the middle of treatment with hydroxychloroquine sulfate (HCQ) or chloroquine phosphate (CQ) for COVID-19 [coronavirus disease 2019] under the EUA? Can my treatment continue to completion?"; "Was the EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) revoked due to a safety issue?"; "Should I be concerned if I was given hydroxychloroquine sulfate or chloroquine phosphate for COVID-19?"; "Can hospitals finish their current supplies of hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ)?"; "Why did FDA grant the EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) for the treatment of COVID-19 initially?"; "Did the agency wait for BARDA to request revocation of the EUA?"; "Did the new information about a potential drug interaction between remdesivir and hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) contribute to the revocation of the EUA?"; "Will clinical trials studying hydroxychloroquine sulfate and chloroquine phosphate for the treatment and prevention of COVID-19 continue?"; and "What impact did FDA's revocation of the EUA covering chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) have on ongoing clinical trials for the treatment or prevention of COVID-19 for these drug products?"

Publisher:
Date:
2020-06-19
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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