On May 25, 2023, the FDA granted approval to Paxlovid™ for the treatment of mild to moderate COVID-19 infections in adult patients who may be at risk of progressing to severe disease. Paxlovid™ originally became available under emergency use authorization (EAU) in 2021, and now it is the first oral antiviral to receive full FDA approval for the treatment of COVID-19. Doses manufactured under the EUA will still be available through the U.S. Department of Health and Human Services to ensure continued access for adults as well as eligible children between ages 12-18 who are not covered by the recent FDA approval. Paxlovid™ was tested in the EPIC-HR trial, studying its efficacy in non-hospitalized, symptomatic adult patients with a confirmed SARS-CoV-2 infection who were not previously vaccinated. The study included adults 18 years and older with prespecified chronic medical conditions or risk factors, as well as patients 60 years and older regardless of risk factor status. Paxlovid™ significantly reduced the rate of COVID-19 hospitalizations or death during the 28 days following treatment. In the study, 977 participants received Paxlovid™, with only 0.9% experiencing hospitalization or death. Of the 989 patients receiving placebo, 6.5% experienced hospitalization or death. In a similar clinical trial of vaccinated adults, Paxlovid™ reduced hospitalizations or death in patients with at least one risk factor for progression to severe COVID-19. Diarrhea and impaired sense of taste are the most common side effects of Paxlovid™. The FDA is providing prescribers with their authorized Fact Sheet for Health Care Providers to reduce the risk of any significant drug-drug interactions when prescribing Paxlovid™. Health care providers are encouraged to assess a patient’s current medications and determine if any potential interactions can be managed and/or if the benefits of the treatment outweigh the risks.