FDA granted the first oral treatment on Dec. 22. The FDA authorized Pfizer’s, Inc.’s (Pfizer) request that the Food and Drug Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for PAXLOVID (nirmatrelvir co-packaged with ritonavir) for treatment of mild-to-moderate COVID-19 in some adults and pediatric patients under the official Section 564 of the Federal Food, Drug, and Cosmetic Act codified in 21 U.S.C. §360bbb-3).
Here is the direct link to the EUA letter. https://www.fda.gov/media/155049/download
In the press release, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research remarked:
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
Direct Link to press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19
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