The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- As part of the FDA’s effort to protect consumers, the agency issued warning letters to operators of two websites (www.hydroxychloroquine-online.com and www.pharmaboosters.com) that market unapproved COVID-19 products. There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Consumers can visit BeSafeRx to learn about how to safely buy medicine online.
- On July 15, 2020, the agency approved an abbreviated new drug application, or generic, for heparin sodium. This drug is an anti-coagulant to prevent blood clotting. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.
- FDA issued Emergency Use Authorizations to:
- Boston Heart Diagnostics for its molecular Boston Heart COVID-19 RT-PCR Test
- Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay
- Testing updates:
- To date, the FDA has currently authorized 184 tests under EUAs; these include 152 molecular tests, 30 antibody tests, and 2 antigen tests.
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