PFE Pfizer Inc

By Colin Kellaher

The U.S. Food and Drug Administration on Thursday said it granted full approval to Pfizer's Paxlovid for high-risk adults, paving the way for the drugmaker to sell the oral antiviral commercially.

The FDA's green light covers Paxlovid for the treatment of mild-to-moderate Covid-19 in adults who are at high risk for progression to a severe case, including hospitalization or death.

Pfizer has been selling Paxlovid to the federal government under an emergency-use authorization, with the government then directing distribution.

The full FDA nod gives Pfizer the ability to sell the drug as it does most of its medicines--with the help of advertising and through intermediaries that distribute it to pharmacies and other buyers.

The FDA said Paxlovid made and packaged under the emergency-use authorization and distributed by the Department of Health and Human Services would remain available to ensure continued access for adults, as well as for children ages 12 to 18 who aren't covered by the full approval.

Paxlovid is the first oral antiviral pill and the fourth drug overall that the FDA has approved to treat Covid-19 in adults.

-Jared S. Hopkins contributed to this article

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 25, 2023 11:08 ET (15:08 GMT)

Pfizer (NYSE:PFE)
過去 株価チャート
から 3 2024 まで 4 2024

Pfizer (NYSE:PFE)
過去 株価チャート
から 4 2023 まで 4 2024