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FDA Accelerates Approvals of Generic Versions of HCQ

U.S. Food and Drug Administration  |  

On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic rheumatoid arthritis in adults.

Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events and hypoglycemia.

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The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. 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.

Reference

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  1. U.S. Food and Drug Administration. News release: Coronavirus (COVID-19) update: Daily roundup April 7, 2020. 2020 Apr 7.

Editor’s note: The ACR offers recommendations regarding the allocation of hydroxychloroquine (HCQ) during the COVID-19 pandemic and recommendations regarding the allocation of IL-1 and IL-6 and JAK antagonists during the pandemic. All recommendations are based on current knowledge and are subject to revision as circumstances evolve.

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