March 16, 2023 Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC)

The committee will discuss new drug application (NDA) 217188, for PAXLOVID (nirmatrelvir and ritonavir co-packaged tablets) for oral use, submitted by Pfizer, Inc. The proposed indication is treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID 19, including hospitalization or death.