COVID pill Paxlovid gets full FDA approval after more than a year of emergency use
By MATTHEW PERRONE
AP Health Writer
WASHINGTON (AP) - Pfizer received full approval on Thursday 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. More than 14,000 new COVID-19 cases were reported each week last month, although most U.S. cases are no longer reported to health authorities.
Paxlovid is the fourth drug for COVID-19 to receive full FDA approval and the first one that is a pill. The previously approved therapies are IV or injectable drugs, typically given at clinics or hospitals.
By The Associated Press, Copyright 2023
text insert webselectnews-2