- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA posted a new resource, At-Home COVID-19 Diagnostic Tests, that provides a list of all FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests. Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19. At-home OTC COVID-19 diagnostic tests play a key role in the fight against COVID-19.
- On Feb. 18, the FDA approved an expanded indication for the Medtronic Freezor and Freezor Xtra Cardiac Cryoablation Catheters to include children at least 2 years of age and older. This approval expands the indication for cryoablation in atrioventricular nodal reentrant tachycardia (AVNRT), a condition that causes episodes of an abnormally fast heartbeat that often start and end suddenly. The device, used in a minimally invasive surgical procedure, uses extremely cold gas to freeze and permanently destroy a tiny area in the heart that is responsible for the abnormally fast heartbeat. The approval also expands the cryothermal mapping feature to the Freezor Xtra catheter. Cryothermal mapping allows the cardiologist to verify the tissue that should be treated prior to permanently destroying that tissue.
- On Feb. 18, the FDA alerted the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. The FDA worked with the company to initiate a voluntary recall of the affected products.
- On Feb. 15, as part of the FDA’s effort to protect consumers, the agency issued warning letters to operators of two websites, Extrapharmacy.ru and Rxshopmd.com for marketing unapproved and misbranded drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- On Feb. 11, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to CytoDyn Inc. for making representations in a promotional context that leronlimab, a drug that has not been approved or authorized by the FDA, is safe and effective for use in treating COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- COVID-19 testing updates:
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 15 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 843 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs