FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the…
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