FDA approves hydroxychloroquine new drug application to address COVID-19 related shortage
The FDA has approved an abbreviated new drug application for hydroxychloroquine sulfate tablets to address ongoing shortages of the drug sparked by its still unproven potential as a COVID-19 treatment. The application, submitted by Accord Healthcare, was approved on April 7. The approved indications are 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.
