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) |
| Revised authorization |
10/27/2022 |
CDER Memorandum (139 KB) |
| Revised authorization |
12/21/2022 |
CDER Memorandum (175 KB) |
Bamlanivimab
Bamlanivimab and Etesevimab
Baricitinib (Olumiant)
Bebtelovimab
Evusheld (tixagevimab co-packaged with cilgavimab)
Gohibic (vilobelimab)
| EUA Action |
Action Date |
CDER Review Document |
| Original authorization |
4/04/2023 |
CDER Review (6 MB) |
Kineret (Anakinra)
| EUA Action |
Action Date |
CDER Review Document |
| Original authorization |
11/08/2022 |
CDER Review (3 MB) |
Lagevrio (molnupiravir)
Paxlovid (Nirmatrelvir and Ritonavir)
Pemgarda (pemivibart)
| EUA Action |
Action Date |
CDER Review Document |
| Original authorization |
3/22/2024 |
CDER Review (8 MB) |
| Revised authorization |
8/26/2024 |
CDER Review (270 KB) |
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 (2 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.
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Content current as of:
08/26/2024
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Regulated Product(s)
Health Topic(s)
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