- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On June 8, 2020, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated in addition to general anesthesia, 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.
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- The FDA issued a warning letter to one company for selling a fraudulent COVID-19 product, as part of the agency’s effort to protect consumers. The seller that received FDA’s warning, organic-beauty-recipes.com, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions on its website for promoting the sale on Amazon of certain products. One essential-oil product promoted by the site is accompanied by misleading claims that this product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA requested the company immediately stop promoting and participating in the sale of the fraudulent COVID-19 product. 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.
- Testing updates:
- To date, the FDA has authorized 128 tests under EUAs, which include 108 molecular tests, 19 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.
- Lee Herring