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  5. CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
  1. Coronavirus (COVID-19) | Drugs

CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

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 ActionAction DateCDER Review Document
Original authorization6/24/2021CDER Review (3 MB)
Revised authorization10/27/2022CDER Memorandum (139 KB)
Revised authorization12/21/2022CDER Memorandum (175 KB)

Bamlanivimab

EUA ActionAction DateCDER Review Document
Original authorization11/9/2020CDER Review (3 MB)
Updates to authorized labeling1/28/2021CDER Memorandum on Fact Sheet Update (100 KB)
Revised authorization2/09/2021CDER Memorandum on Fact Sheet Update (79 KB)
Revised authorization2/25/2021CDER Memorandum (78 KB)
Updates to authorized labeling3/18/2021CDER Memorandum on Fact Sheet Update (103 KB)
Revocation4/16/2021Recommendation for Revocation of EUA 090  (309 KB)

Bamlanivimab and Etesevimab

EUA ActionAction DateCDER Review Document
Original authorization2/09/2021CDER Review (6 MB)
Revised authorization2/25/2021CDER Memorandum (84 KB)
Updates to authorized labeling3/18/2021CDER Memorandum on Fact Sheet Update (267 KB)
Updates to authorized labeling5/14/2021CDER Memorandum on Fact Sheet Update (356 KB)
Revised authorization8/27/2021CDER Memorandum (213 KB)
Authorization update9/2/2021CDER Memorandum​ (69 KB)
Authorization update9/8/2021CDER Memorandum (25 KB)
Revised authorization9/16/2021CDER Review (4 MB)
Revised authorization12/22/2021CDER Review (154 KB)
Revised authorization1/24/2022CDER Memorandum (141 KB)
Revocation12/14/2023CDER Memorandum (40 KB)

Baricitinib (Olumiant)

EUA ActionAction DateCDER Review Document
Original authorization11/19/2020CDER Review (1 MB)
Revised authorization7/28/2021CDER Memorandum (516 KB)
Updates to authorized labeling10/7/2021CDER Review (446 KB)
Revised authorization12/20/2021CDER Memorandum (264 KB)
Revised authorization5/10/2022CDER Review (19 KB)
Revised authorization10/27/2022CDER Memorandum (139 KB)

Bebtelovimab

EUA ActionAction DateCDER Review Document
Original authorization2/11/2022CDER Review (2 MB)
Updates to authorized labeling3/25/2022CDER Memorandum (137 KB)
Updates to authorized labeling5/18/2022CDER Memorandum (429 KB)
Revised authorization10/27/2022CDER Memorandum (139 KB)
Updates to authorized labeling11/3/2022CDER Memorandum (89 KB)
Update to Authorization11/30/2022CDER Memorandum (197 KB)

Evusheld (tixagevimab co-packaged with cilgavimab)

EUA ActionAction DateCDER Review Document
   
Original authorization12/08/2021CDER Review (7 MB)
Revised authorization2/24/2022CDER Memorandum (2 MB)
Updates to authorized labeling4/1/2022CDER Memorandum (PDF - 30 KB)
Revised authorization5/17/2022CDER Memorandum (PDF - 63 KB)
Updates to authorized labeling6/29/2022CDER Memorandum (PDF - 502 KB)
Updates to authorized labeling6/29/2022CDER Memorandum (389 KB)
Updates to authorized labeling9/30/2022CDER Memorandum (52 KB)
Revised authorization10/27/2022CDER Memorandum (139 KB)
Revised authorization1/26/2023CDER Memorandum (186 KB)

Gohibic (vilobelimab)

EUA ActionAction DateCDER Review Document
Original authorization4/04/2023CDER Review (6 MB)

Kineret (Anakinra)

EUA ActionAction DateCDER Review Document
Original authorization11/08/2022CDER Review (3 MB)

Lagevrio (molnupiravir)

EUA ActionAction DateCDER Review Document
Original authorization12/23/2021CDER Review (7 MB)
Revised authorization2/11/2022CDER Memorandum (PDF - 948 KB)
Revised Authorization3/23/2022CDER Review (PDF - 928 KB)
Revised Authorization8/5/2022Clinical Virology Review (PDF - 2.09 MB)
Revised authorization10/27/2022CDER Memorandum (139 KB)
Revised authorization2/1/2023CDER Memorandum (358 KB)
Continuing Review2/17/2023CDER Memorandum (505 KB)
Revised Authorization10/3/2023CDER Memorandum (171 KB)

Paxlovid (Nirmatrelvir and Ritonavir)

EUA ActionAction DateCDER Review Document
Original authorization12/22/2021CDER Review (4 MB)
Updates to authorized labeling2/23/2022CDER Review (28 KB)
Updates to authorized labeling3/18/2022CDER Review (274 KB)
Updates to authorized labeling4/8/2022CDER Clinical Pharmacology Review (117 KB)
Updates to authorized labeling6/28/2022CDER Memorandum (4 MB)
Revised Authorization7/6/2022CDER Review (27 KB)
Revised Authorization8/5/2022CDER Memorandum (PDF - 46 KB)
Updates to authorized labeling8/25/2022CDER Review (2 MB)
Updates to authorized labeling9/26/2022CDER Memorandum (49 KB)
Updates to authorized labeling9/26/2022Clinical Virology Review (699 KB)
Revised authorization10/27/2022CDER Memorandum (139 KB)
Revised authorization2/1/2023CDER Memorandum (56 KB)
Revised authorization5/25/2023CDER Memorandum (550 KB)
Revised authorization11/1/2023CDER Memorandum (40 KB)
Revised authorization1/29/2024CDER Memorandum (21 KB)
Revised authorization3/12/2024CDER Memorandum (133 KB)
Updates to authorized labeling1/31/2025CDER Memorandum (49 KB)

Pemgarda (pemivibart)

EUA ActionAction DateCDER Review Document
Original authorization3/22/2024CDER Review (8 MB)
Revised authorization8/26/2024CDER Review (270 KB)
Updates to authorized labeling9/26/2024CDER Memorandum on Fact Sheet Update (429.6 KB)

Propofol-Lipuro 1%

EUA ActionAction DateCDER Review Document
Original authorization3/12/2021CDER Review (1 MB)

REGEN-COV (Casirivimab and Imdevimab)

EUA ActionAction DateCDER Review Document
Original authorization11/21/2020CDER Review (3 MB)
Revised authorization2/03/2021CDER Review (136 KB)
Revised authorization2/25/2021CDER Memorandum (52 KB)
Updates to authorized labeling3/18/2021 CDER Revie​w (70 KB)
Updates to authorized labeling5/14/2021CDER Review (83 KB)
Revised authorization6/3/2021CDER Review​ (952.09 KB)
Revised authorization7/30/2021CDER Review (1.1 MB)
Updates to authorized labeling8/17/2021CDER Clinical Virology Review (382 KB)
Updates to authorized labeling11/17/2021CDER EUA Review (219 KB)
Updates to authorized labeling12/22/2021CDER Memorandum (88 KB)
Revised authorization1/24/2022CDER Memorandum (168 KB)

Sotrovimab

EUA ActionAction DateCDER Review Document
Original authorization5/26/2021CDER Review (2 MB)
Updates to authorized labeling7/9/2021CDER Memorandum on Fact Sheet Update (128 KB)
Updates to authorized labeling9/23/2021CDER Memorandum on Fact Sheet Update (190 KB)
Updates to authorized labeling11/1/2021CDER Memorandum on Fact Sheet Update (162 KB)
Updates to authorized labeling12/22/2021CDER Memorandum on Fact Sheet Update (159 KB)
Revised authorization2/23/2022CDER Memorandum (891 KB)
Updates to authorized labeling3/25/2022CDER Memorandum (2 MB)

VEKLURY (Remdesivir)

EUA ActionAction DateCDER Review Document
Revised Authorization1/21/2022CDER 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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