Coronavirus (COVID-19) Update: June 4, 2021
- For immediate release:
The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:
- On June 1, the FDA approved an abridged new drug application for albuterol sulfate inhalation aerosol 90 mcg (base) / actuation. Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients aged four years. of age and over. The most common side effects associated with albuterol sulfate inhalation aerosol are headache, dizziness, tachycardia (rapid heartbeat), chest pain, pharyngitis (sore throat), and rhinitis ( runny nose).
FDA recognizes increased demand for certain products during COVID-19 public health emergency and has prioritized reviewing generic drug applications for potential treatments and supportive therapies for patients with COVID-19 . We remain deeply committed to facilitating access to safe and effective medical products to help meet the critical needs of the American public.
- On June 3, the FDA released an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests webpage to share the latest information. The update added new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 assay due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples .
- The FDA has reissued the REGEN-COV Treatment Authorization Letter (Casirivimab and Imdevimab) for COVID-19 to authorize:
- Testing updates:
- To date, 380 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUA). These include 275 molecular tests and specimen collection devices, 80 antibody tests and other immune response tests, and 25 antigen tests. There are 52 molecular clearances and one antibody clearance that can be used with home samples. There is one at-home molecular prescription test, two at-home antigen prescription tests, four at-home over-the-counter (OTC) antigen tests, and two at-home over-the-counter molecular tests.
- The FDA has authorized nine antigen tests and three molecular tests for serial screening programs. The FDA has also cleared 525 reviews of EUA authorizations.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.