FDA Approves ANDA for Hydroxychloroquine to Tackle COVID-19-related Shortage

The US Food and Drug Administration (FDA) approved an abbreviated new drug application for hydroxychloroquine sulfate tablets (200 mg) to address the drug shortage due to its unproven potential as a coronavirus disease 2019 (COVID-19) treatment.

The application was approved on April 7, 2020 and the FDA-approved indications are for the treatment of uncomplicated malaria due to Plasmodium falciparum, P. malariae,P. ovale, and P. vivax; chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and acute and chronic rheumatoid arthritis in adults.

The shortage came after it was broadly reported in March that hydroxychloroquine could potentially help shorten the course of COVID-19. Rheumatologists have expressed their concerns as many patients report not being able to fill prescriptions for hydroxychloroquine.

“The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis,” said the FDA in the statement on their website. 

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.

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