The FDA has 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, according to an agency EUA announcement.
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 agency said.
Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, the FDA authorization explained.
The drugs are already FDA-approved to treat malaria and other diseases, and the agency encouraged healthcare providers to engage in randomized controlled clinical trials to document COVID-19 effectiveness of the drugs.
The Assistant Secretary for Preparedness and Response and Federal Emergency Management Agency will ship donated doses to states, the FDA reported.