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Paxlovid FDA Approval Status

Last updated by Philip Thornton, DipPharm on July 21, 2022.

FDA Approved: No (Emergency Use Authorization)
Brand name: Paxlovid
Generic name: nirmatrelvir [PF-07321332] tablets and ritonavir tablets
Company: Pfizer Inc.
Treatment for: COVID-19

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets co-packaged) has emergency use authorization (EUA) from the FDA to treat mild-to-moderate COVID-19 in adults and pediatric patients who are 12 years of age and older and weigh at least 40 kg (88 lbs). Patients must have a positive direct SARS-CoV-2 viral test and be at high risk for progression to severe COVID-19, including hospitalization or death.

  • Pfizer filed a New Drug Application (NDA) with the FDA for full regulatory approval of Paxlovid on June 30, 2022.
  • Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions.
  • Paxlovid is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One box contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Treatment should start as soon as possible after a positive SARS-CoV-2 viral test to potentially help patients avoid severe illness.
  • Paxlovid contains the novel antiviral nirmatrelvir (PF-07321332) which works by blocking the activity of SARS-CoV-2 main protease (Mpro), also known as SARS-CoV2 3CL protease, an enzyme that the coronavirus that causes COVID-19 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.
  • In vitro data confirm that nirmatrelvir is a potent inhibitor of the Omicron 3CL protease, which, combined with existing in vitro antiviral and protease inhibition data from other Variants of Concern (VoC) including Delta, indicates that Paxlovid will retain robust antiviral activity against current VoCs as well as other coronaviruses.
  • Final data from the EPIC-HR study confirmed that Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.

Development timeline for Paxlovid

Jul 20, 2022FDA Authorizes Pharmacists to Prescribe Paxlovid
Jun 30, 2022Pfizer Announces Submission of New Drug Application to the U.S. FDA for Paxlovid
Jun 14, 2022Pfizer Reports Additional Data on Paxlovid Supporting Upcoming New Drug Application Submission to U.S. FDA
Apr 29, 2022Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of Paxlovid for Post-Exposure Prophylactic Use
Mar  9, 2022Pfizer Initiates Phase 2/3 Study of Novel COVID-19 Oral Treatment in Pediatric Participants
Jan 18, 2022Pfizer Shares In Vitro Efficacy of Paxlovid Novel COVID-19 Oral Treatment Against Omicron Variant
Dec 22, 2021Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment Paxlovid
Dec 14, 2021Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death
Nov 16, 2021Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate Paxlovid
Nov  5, 2021Pfizer’s Covid-19 Oral Antiviral Treatment Paxlovid Reduces Risk of Hospitalization and Death
Mar 23, 2021Pfizer Initiates Phase 1 Study of Novel Oral Antiviral Therapeutic Agent PF-07321332 Against SARS-CoV-2

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.