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FDA Roundup: August 2, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • On Monday, the FDA announced the approval of the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses.
  • On Monday, the FDA announced the availability of a final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). This guidance explains our intent to exercise enforcement discretion with respect to the sale and distribution of NAC-containing products that are labeled as dietary supplements, would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement,” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • COVID-19 testing updates: 
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1062 revisions to EUA authorizations. 
       

Related Information

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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.


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