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Navigating the FDA’s Revised Authorization and Ensuring a Seamless Transition from Emergency-Use-Labeled Paxlovid to Approved Labeling

In December 2021, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for Pfizer’s novel antiviral drug Paxlovid, ushering in a new tool for managing severe COVID-19 cases in individuals with a high risk of serious illness. By May 2023, the FDA had further validated Paxlovid’s efficacy by approving its new drug application (NDA) specifically for the treatment of mild-to-moderate COVID-19 in adults who also belong to the high-risk category. The most recent development is a revision in the Paxlovid EUA, which has implications for its continued availability and use.

Under this revision, the FDA stipulates that Paxlovid manufactured under the EUA, referred to as EUA-labeled Paxlovid, currently in circulation will retain its authorized status until the earlier of its labeled expiration date or March 8, 2024. However, this authorization will stand void after this stipulated cutoff, regardless of the drug’s printed expiration date. This transition, which began on November 1, 2023, with the rollout of FDA-approved Paxlovid, designated NDA-labeled Paxlovid, is the next phase in the process of phased adoption of NDA-labeled Paxlovid.

The revised EUA continues to allow the emergency use of NDA-labeled Paxlovid for treating mild-to-moderate COVID-19 in pediatric patients over 12 years who belong to the high-risk group. To facilitate the gradual shift from EUA-labeled to NDA-labeled Paxlovid, the FDA is offering specific details on the timeline of this transition. This directive primarily impacts dispensary sites, including pharmacies, urging them to stock up on the NDA-labeled drug to ensure its continued availability.

Healthcare providers and pharmacists are allowed to dispense valid EUA-labeled Paxlovid in accordance with the EUA guidelines until March 8, 2024. Beyond this date, they must return or duly dispose of any expired EUA-labeled Paxlovid in accordance with established rules and regulations. After March 8, 2024, any remaining EUA-labeled Paxlovid must also be disposed of or returned in adherence to regulatory requirements.

Patients who have been prescribed Paxlovid will receive either EUA-labeled or NDA-labeled Paxlovid till March 8, 2024. Thereafter, they will only receive NDA-labeled Paxlovid. Patients who have been prescribed EUA-labeled Paxlovid on or before the March cut-off and who have initiated their treatment cycle can continue their use past this date. Furthermore, eligible patients, including those enrolled in the PAXCESS program, can avail of free Paxlovid until December 31, 2024. For any queries regarding expiration dates and other updates, the FDA recommends contacting a pharmacist and checking Pfizer’s official website.


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