Pfizer Files For FDA Emergency Use Nod For Its COVID-19 Antiviral Pill

Pfizer Inc PFE is seeking FDA emergency use authorization of its experimental antiviral COVID-19 pill.
Pfizer said it submitted its application for emergency use authorization (EUA) of the drug, Paxlovid, with the agency.
Related: Link: Pfizer Touts Encouraging Data For Its COVID-19 Oral Antiviral, With 89% Reduction In Hospitalization, Death.
A panel of outside advisers to the FDA will meet to consider the application on November 30. It is expected to be available this year.
If approved, Paxlovid will be administered in two 150 mg tablets and one 100 mg tablet of HIV drug, ritonavir, twice daily for five days.
Pfizer said it has begun the process of seeking authorization of the treatment in several countries, including the U.K., Australia, New Zealand, and South Korea, and plans further international submissions.
Yesterday, Pfizer said it would allow generic manufacturers to supply its COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with the international public health group Medicines Patent Pool (MPP).
Related content: Benzinga's Full FDA Calendar.
Price Action: PFE shares are up 1.07% at $50.13 during the market session on the last check Wednesday.

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