To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER is disclosing information from our scientific review documents supporting Emergency Use Authorizations (EUA) for drug and biological therapeutic products as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals. Certain information may be redacted that is exempt from disclosure un2er the Freedom of Information Act (FOIA), 5 U.S.C. sec. 552, such as trade secrets or other information identified by the EUA requestors that is exempt under FOIA. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to the release of information that is exempt under FOIA.

Actemra (tocilizumab)

EUA Action Action Date CDER Review Document
Original authorization 6/24/2021 CDER Review (3 MB)

Bamlanivimab

Bamlanivimab and Etesevimab

Baricitinib (Olumiant)

EUA Action Action Date CDER Review Document
Original authorization 11/19/2020 CDER Review (1 MB)
Revised authorization 7/28/2021 CDER Memorandum (516 KB)
Updates to authorized labeling 10/7/2021 CDER Review (446 KB)
Revised authorization 12/20/2021 CDER Memorandum (264 KB)
Revised authorization 5/10/2022 CDER Review (19 KB)

Bebtelovimab

EUA Action Action Date CDER Review Document
Original authorization 2/11/2022 CDER Review (2 MB)
Updates to authorized labeling 3/25/2022 CDER Memorandum (137 KB)
Updates to authorized labeling 5/18/2022 CDER Memorandum (429 KB)

Evusheld (tixagevimab co-packaged with cilgavimab)

EUA Action Action Date CDER Review Document
Original authorization 12/08/2021 CDER Review (7 MB)
Revised authorization 2/24/2022 CDER Memorandum (2 MB)
Updates to authorized labeling 4/1/2022 CDER Memorandum (PDF - 30 KB)
Revised authorization 5/17/2022 CDER Memorandum (PDF - 63 KB)
Updates to authorized labeling 6/29/2022 CDER Memorandum (PDF - 502 KB)

Lagevrio (molnupiravir)

Paxlovid (Nirmatrelvir and Ritonavir)

Propofol-Lipuro 1%

EUA Action Action Date CDER Review Document
Original authorization 3/12/2021  CDER Review (1 MB)

REGEN-COV (Casirivimab and Imdevimab)

Sotrovimab

VEKLURY (Remdesivir)

EUA Action Action Date CDER Review Document
Revised Authorization 1/21/2022 CDER Memorandum (1.77 MB)

To access the Letters of Authorization and Fact Sheets for Healthcare Providers and Patients, Parents, and Caregivers for EUAs for drug and biological products during the COVID-19 pandemic, see FDA’s webpage on Emergency Use Authorization.