TherapeuticsOn March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Hydroxychloroquine Sulfate Fact Sheet for Healthcare Providers (PDF, 206 KB)
https://www.fda.gov/media/136537/download
Hydroxychloroquine Sulfate Fact Sheet for Patients (PDF, 148 KB)
EUA Hydroxychloroquine Phosphate Patients and Parent/Caregivers Fact Sheet, version date 3/28/20FACT SHEET FOR PATIENTS AND PARENT/CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF HYDROXYCHLOROQUINE SULFATE FOR TREATMENT OF COVID-19 IN CERTAIN HOSPITALIZED PATIENTS
https://www.fda.gov/media/136538/download
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