- For immediate release:
The United States Food and Drug Administration (FDA) continued to act in response to the ongoing response to the COVID-19 pandemic:
- On November 20, the FDA approved an abbreviated new drug application for Succinylcholine Chloride Injection USP 200mg / 10ml, which, in addition to general anesthesia, is indicated to facilitate tracheal intubation and to relax skeletal muscles during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalaemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain strongly committed to facilitating access to safe and effective medical products to meet critical needs of the American public .
- The FDA issued an EUA on November 21 for casirivimab and imdevimab, co-administered by intravenous (IV) infusion, for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) [about 88 pounds]) with positive results from direct SARS-CoV-2 viral testing and are at high risk of progressing to severe COVID-19. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk of disease progression within 28 days of treatment compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 is still being evaluated. Casirivimab and imdevimab are not approved for patients admitted to hospital because of COVID-19 or who require oxygen therapy because of COVID-19.
- The FDA also recently posted a new infographic, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, to explain a potential route for vaccines.
- To test updates:
- As of Nov. 18, 289 tests have been approved by the FDA under EUAs; these include 224 molecular tests, 58 antibody tests, and 7 antigen tests.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.