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Pfizer COVID drug Paxlovid gets USFDA emergency use nod
New York: Pfizer Inc. has recently announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral...
New York: Pfizer Inc. has recently announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate.
Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow. The company also plans to file a New Drug Application (NDA) with the FDA in 2022 for potential full regulatory approval.
Read also: USFDA to authorize Pfizer, Merck COVID pills this week: Report
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751