Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., May 5, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

    --  The FDA and Federal Trade Commission (FTC) issued warning letters to two
        companies for selling fraudulent COVID-19 products, as part of the
        agency's effort to protect consumers. There are currently no
        FDA-approved products to prevent or treat COVID-19. Consumers concerned
        about COVID-19 should consult with their health care provider.
        --  The first seller warned, Honey Colony LLC, offers products including
            "Quicksilver Liposomal Vitamin C w/ Liposomal," "Jigsaw Magnesium
            With SRT," and products labeled to contain silver, including "Silver
            Excelsior Serum", for sale in the U.S. with misleading claims that
            the products are safe and/or effective for the prevention and
            treatment of COVID-19.


        --  The second seller warned, Dr. Dhole's Sushanti Homeopathy Clinic,
            offers products including "Homeopathic Genus Epidemicus" for sale in
            the U.S. with misleading claims that the product is safe and/or
            effective for the prevention of COVID-19.


    --  Yesterday, FDA approved two generic drugs indicated to facilitate
        tracheal intubation and to provide skeletal muscle relaxation during
        surgery or mechanical ventilation: succinylcholine chloride injection
        USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.
        FDA recognizes the increased demand for certain products during the
        novel coronavirus pandemic and we remain deeply committed to
        facilitating access to medical products to help address critical needs
        of the American public.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 385
            test developers who have said they will be submitting EUA requests
            to the FDA for tests that detect the virus.
        --  To date, the FDA has issued 59 individual EUAs for test kit
            manufacturers and laboratories. In addition, 25 authorized tests
            have been added to the EUA letter of authorization for high
            complexity molecular-based laboratory developed tests (LDTs).
        --  The FDA has been notified that more than 240 laboratories have begun
            testing under the policies set forth in our COVID-19 Policy for
            Diagnostic Tests for Coronavirus Disease-2019 during the Public
            Health Emergency Guidance.
        --  The FDA also continues to keep its COVID-19 Diagnostics FAQ up to
            date.

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Molly.Block@fda.hhs.gov, 240-701-7422
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration