💊FDA Revokes Emergency Use Authorizations for COVID-19 Drugs
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Summary
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The revocation of Emergency Use Authorizations (EUAs) for specific COVID-19 therapeutics affects businesses engaged in pharmaceuticals and healthcare, as it impacts market access, product availability, and potential revenue streams. Companies should prepare for market shifts and consider implications for future product development and regulatory compliance.