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Manila Bulletin devider Philippines devider National devider FDA grants EUA for Pfizer's Covid-19 pill Paxlovid

FDA grants EUA for Pfizer's Covid-19 pill Paxlovid

Published Mar 11, 2022 02:22 pm

FDA

The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to Pfizer's Covid-19 treatment drug Paxlovid.

"Masaya kong ibinabalita sa inyo na naaprubahan na po namin ang Paxlovid kahapon (I'm glad to announce that we already approved Paxlovid yesterday)," said FDA Director Oscar Gutierrez on Friday, March 1, during a public briefing.

"So dalawa na po ang oral antiviral treatment natin (we have two oral antiviral treatments) against COVID-19---Paxlovid and Molnupiravir," he added.

Based on the EUA document, the FDA said Paxlovid can be used for the "treatment of mild to moderate" Covid-19 among patients aged 18 years old and above and "who are at increased risk for progression to severe Covid-19."

The FDA said that "based on the totality of evidence available to date, including data from adequate and well- known controlled trials, it is reasonable to believe" that the Paxlovid "may be effective” to treat Covid-19.

Paxlovid is an oral medication and should be taken twice daily for five days.

"This should be given as soon as possible after a diagnosis of Covid-19 has been made and within five days of symptom onset," the FDA said.

This drug is "not recommended for women with childbearing potential, pregnant and lactating women," it added.

Related Tags

Emergency Use Authorization Food and Drug Administration PAXLOVID
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