Coronavirus (COVID-19) Update: Daily Roundup May 19, 2020

FDA News Release

• For Immediate Release: May 19, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, the FDA approved succinylcholine chloride injection USP 200 mg/10 mL, which is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. 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.
• Testing updates:
  • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
  • To date, the FDA has authorized 104 tests under EUAs, which include 91 molecular tests, 12 antibody tests, and 1 antigen test.

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.