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FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid – Drugs.com MedNews

January 29, 2024 — In December 2021, FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. In May 2023, FDA approved Pfizer’s 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.

Today, FDA is announcing 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.

EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. However, the Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the NDA (NDA-labeled Paxlovid) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

This revision to the Paxlovid EUA is the next phase in the transition from the use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid. This transition began on November 1, 2023, with the introduction of FDA-approved Paxlovid (NDA-labeled Paxlovid).1,2

To ensure ongoing availability of Paxlovid at the point of dispensing and to facilitate a smooth transition to FDA-approved Paxlovid (NDA-labeled Paxlovid), we are providing information in the revised authorization on the timing of the shift from the use of EUA-labeled Paxlovid to NDA-labeled Paxlovid so that dispensing sites (e.g., pharmacies) that have not yet transitioned to NDA-labeled Paxlovid have time to do so.

Impact on Pharmacies, Pharmacists, and Other Health Care Providers

Through March 8, 2024, unexpired EUA-labeled Paxlovid can be dispensed to patients when consistent with the terms and conditions of the EUA. See the Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 for additional information related to the dispensing of Paxlovid.

Both providers and patients should visit Pfizer’s website for information on lots of EUA-labeled Paxlovid that are the subject of a shelf-life extension. Lots of EUA-labeled Paxlovid not listed on Pfizer’s website may only be used through the labeled expiration date, or through March 8, 2024, whichever is earlier.

Expired EUA-labeled Paxlovid must be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations. Similarly, after March 8, 2024, all EUA-labeled Paxlovid remaining in U.S. distribution must also be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations.

Impact on Patients

Patients who have a prescription for Paxlovid will continue to receive either EUA-labeled or NDA-labeled Paxlovid through March 8, 2024. After that date, they will receive NDA-labeled Paxlovid. More information about Paxlovid, including the differences in packaging between EUA-labeled and NDA-labeled Paxlovid, is available at FDA’s frequently asked questions and answers.

Patients who receive a prescription of EUA-labeled Paxlovid on or prior to March 8, 2024, and have initiated treatment on or prior to that date, may complete their course of treatment even if completion of treatment were to occur after March 8, 2024. If patients have a question about the expiration date on the box of Paxlovid they have received, they should talk with their pharmacist and can also check Pfizer’s website for updated expiration dates.

Through December 31, 2024, eligible patients qualify for free Paxlovid through the PAXCESS program. Eligible patients include Medicare beneficiaries, Medicaid beneficiaries, and uninsured individuals who do not have a prescription drug benefit at the time they fill their prescription. Patients who are commercially insured may be eligible for assistance though a co-pay savings program.

Additional Resources

  • Letter of Authorization for EUA Paxlovid
  • FDA’s Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19
  • Health and Human Services Guidance on Sunsetting of the US Government’s COVID-19 Therapeutics Distribution Program.
  • Paxlovid landing page at Health and Human Services’ Administration for Strategic Preparedness & Response.
  • To review information about the commercial availability of Paxlovid, read Pfizer’s statement.
  • For questions on how to obtain approved Paxlovid, please visit Pfizer’s Paxlovid page.

1 FDA Roundup: November 3, 2023: https://www.fda.gov/news-events/press-announcements/fda-roundup-november-3-2023

2 Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program: https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/COVID19-Tx-Transition-Guide.aspx

Source: FDA

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