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Pfizer COVID pill Paxlovid gets full FDA approval

WASHINGTON (AP) - Pfizer received full approval recently for its COVID-19 pill Paxlovid that’s been the go-to treatment against the coronavirus.

More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research.

The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity.

The decision allows Pfizer’s drug to remain on the market indefinitely and to be marketed similarly to other drugs.

The pill is still available for children ages 12 to 17 under a separate emergency authorization.

The U.S. government has stockpiled millions of doses of Paxlovid and patients will continue to receive it at no charge, the FDA said in a statement.

Paxlovid is the fourth drug for COVID-19 to receive full FDA approval and the first one that is a pill.

FILE - The anti-viral drug Paxlovid is displayed in New York, Monday, Aug. 1, 2022. Pfizer received full approval for the COVID-19 medication on Thursday, May 25, 2023, winning the U.S. Food and Drug Administration's full endorsement for a drug that has been the go-to treatment against the virus for more than two years. (AP Photo/Stephanie Nano, File)