Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Gilead Sciences, Inc. (Gilead) for VEKLURY (remdesivir). FDA revoked the Authorization on April 25, 2022, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) given the approval of a supplemental new drug application (NDA) for VEKLURY, which expanded the approved indication to cover the authorized population. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.