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:

  • Today, the FDA announced that it has found certain batches of the Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Md., To be acceptable for potential export. Use of the AstraZeneca vaccine is not authorized in the United States, but the FDA understands that these lots of AstraZeneca, or the vaccine made from the lots, will now be exported for use. The agency conducted a thorough review of the facility records and the results of the manufacturer’s quality tests and made its decision based on that review, taking into account the current global public health emergency COVID- 19.
  • On August 3, as part of the FDA’s efforts to protect consumers, the agency sent a warning letter to Blue Willow Biologics for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult their health care provider.
  • On August 4, the FDA approved an Abbreviated New Drug Application for Dexamethasone Sodium Phosphate Injection. Dexamethasone injection is used to treat conditions such as arthritis, blood disorders, hormonal disorders, allergic reactions, skin diseases, eye disorders, breathing problems, bowel disorders, cancer and immune system disorders. Side effects include fluid retention, sodium retention, impaired wound healing, and muscle weakness. This drug is included in the FDA Drug Shortage Database and the Temporary Policy to Prepare Certain Drugs for Inpatients by Contract Facilities During the COVID-19 Public Health Emergency. 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.
  • Testing updates:
    • To date, 399 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUA). These include 279 molecular tests and specimen collection devices, 87 antibody tests and other immune response tests, and 33 antigen tests. There are 53 molecular clearances and one antibody clearance that can be used with home samples. There is one at-home molecular prescription test, three at-home antigen prescription tests, six at-home over-the-counter (OTC) antigen prescription tests, and two at-home over-the-counter molecular tests.
    • The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also cleared 596 reviews of EUA authorizations.

Related information

###

Boilerwork

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.