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FDA Announces Changes to Emergency Use Label for Paxlovid

In a significant update for healthcare providers engaged in the fight against COVID-19, the Food and Drug Administration (FDA) has pronounced that Paxlovid, a therapeutic drug developed by Pfizer, may no longer be distributed under an emergency use label post March 8. According to the new guidelines, providers may continue to dispense any leftover Paxlovid inventory labeled for emergency use to patients till March 8. Post this date, any Paxlovid drugs carrying the emergency use label must either be returned to the manufacturer or disposed of as per laid down regulations.

As a recap, the FDA had given its approval for a new drug application for Paxlovid last May. This decision was made in light of the drug’s demonstrated effectiveness in treating adults who are at a high risk of their COVID-19 symptoms progressing to a severe or critical level. However, this new regulation does not preclude Paxlovid labeled under the new drug application from being used for emergency treatment. It may still be authorized for emergency use for eligible pediatric patients, according to the FDA.

As healthcare professionals keen on infection prevention and control procedures, it’s important to be mindful of and adhere to these regulations regarding the use of Paxlovid.

Source: https://www.aha.org/news/headline/2024-01-29-fda-paxlovid-no-longer-labeled-emergency-use-after-march-8

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