Paxlovid FDA Approval History
Last updated by Judith Stewart, BPharm on March 14, 2024.
FDA Approved: Yes (First approved May 25, 2023)
Brand name: Paxlovid
Generic name: nirmatrelvir and ritonavir
Dosage form: Tablets (co-packaged)
Company: Pfizer Inc.
Treatment for: COVID-19
Paxlovid (nirmatrelvir and ritonavir) is a co-packaged product containing nirmatrelvir, a SARS-CoV-2 main protease inhibitor, and ritonavir, a HIV-1 protease inhibitor and CYP3A inhibitor, indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Paxlovid is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19.
- Paxlovid contains the antiviral nirmatrelvir, which works by blocking the activity of SARS-CoV-2 main protease (Mpro), also known as SARS-CoV2 3CL protease, an enzyme that the SARS-CoV-2 virus needs to replicate. Co-administration with low dose ritonavir helps slow the metabolism of nirmatrelvir allowing it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
- Paxlovid treatment should be initiated as soon as possible after COVID-19 diagnosis, and within 5 days of symptom onset.
- Paxlovid tablets are administered orally, with or without food. Two nirmatrelvir 150 mg tablets and one ritonavir 100 mg tablet are taken together twice daily for 5 days.
- The product label for Paxlovid carries a Boxed Warning for significant drug interactions with ritonavir. Ritonavir is a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events.
- Warnings and precautions associated with Paxlovid include hypersensitivity reactions, hepatotoxicity, and the risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
- Common adverse reactions include dysgeusia (altered taste) and diarrhea.
- - On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for Paxlovid.
- On May 25, 2023, the FDA approved a New Drug Application (NDA) for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid remained available for eligible adolescents, 12 to 17 years of age (and weighing at least 40 kg), under the EUA.
- On October 30, 2023, Pfizer announced that Paxlovid labeled and packaged in accordance with the approved NDA would be available beginning November 1, 2023. The Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services also announced its transition from and winding down of the U.S. government’s distribution of Paxlovid that is labeled and packaged in accordance with the EUA. Pfizer will assume responsibilty for distribution of the treatment after December 15, 2023.
- On November 1, 2023, FDA revised the EUA for Paxlovid to authorize NDA labeled Paxlovid for the treatment of mild-to-moderate COVID-19 in adolescents at high risk for progression to severe COVID-19. During the period of transition, either NDA-labeled Paxlovid or EUA-labeled Paxlovid can be used for the treatment of both adults and adolescents consistent with the approved and authorized labeling as appropriate.
- On January 29, 2024, the FDA announced a revision to the Paxlovid emergency use authorization (EUA), stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier.
- On March 13, 2024, the FDA advised that Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date.
Development timeline for Paxlovid
Further information
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