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The FDA is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic. For CDER, these efforts include accelerating development of treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to stakeholders, advising developers on how to handle clinical trial issues and keeping the public informed. Information on some of CDER’s efforts related specifically to drugs and COVID-19 can be found in the 2020 and the 2021 issues of the newsletter (click here to access the 2020 and 2021 issues) and at the webpages below:
Some recent updates are provided below:
COVID-19 EMERGENCY USE AUTHORIZATIONS AND UPDATES
FDA makes changes to the authorized use of the monoclonal antibodies bamlanivimab and etesevimab, administered together.
August 27, 2021: The Emergency Use Authorization(EUA) now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Read more here.
September 2, 2021 Update: Based on FDA’s evaluation of the most recently available SARS-CoV-2 variant frequency data, bamlanivimab and etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions under the conditions of authorization for EUA 94. Read more here.
September 16, 2021: The FDA revised the EUA for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. Read more here.
FDA approves an abbreviated new drug application on September 3, 2021 for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures. Read more here.
Why you should not use ivermectin to treat or prevent COVID-19?
Some people are taking the drug ivermectin, in some cases the version intended for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use and it may be unsafe to use the drug for this purpose. Read more here.
FDA Issues COVID-19 Relevant Guidances
September 9, 2021: The FDA revised the guidance,” Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers”, originally published in April 2021.
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