Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
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.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.