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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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 Coronavirus
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