Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Eli Lilly and Co. (Lilly), for bamlanivimab and etesevimab administered together. FDA revoked the Authorization on December 14, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Abstract as published in the Federal Register.
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