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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 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

EUA Action Action Date CDER Review Document
Original authorization 11/9/2020 CDER Review (3 MB)
Updates to authorized labeling 1/28/2021 CDER Memorandum on Fact Sheet Update (100 KB)
Revised authorization 2/09/2021 CDER Memorandum on Fact Sheet Update (79 KB)
Revised authorization 2/25/2021 CDER Memorandum (78 KB)
Updates to authorized labeling 3/18/2021 CDER Memorandum on Fact Sheet Update (103 KB)
Revocation 4/16/2021 Recommendation for Revocation of EUA 090  (309 KB)

Bamlanivimab and Etesevimab

EUA Action Action Date CDER Review Document
Original authorization 2/09/2021 CDER Review (6 MB)
Revised authorization 2/25/2021 CDER Memorandum (84 KB)
Updates to authorized labeling 3/18/2021 CDER Memorandum on Fact Sheet Update (267 KB)
Updates to authorized labeling 5/14/2021 CDER Memorandum on Fact Sheet Update (356 KB)
Revised authorization 8/27/2021 CDER Memorandum (213 KB)
Authorization update 9/2/2021 CDER Memorandum​ (69 KB)
Authorization update 9/8/2021 CDER Memorandum (25 KB)
Revised authorization 9/16/2021 CDER Review (4 MB)
Revised authorization 12/22/2021 CDER Review (154 KB)
Revised authorization 1/24/2022 CDER Memorandum (141 KB)
Revocation 12/14/2023 CDER Memorandum (40 KB)

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)
Revised authorization 10/27/2022 CDER Memorandum (139 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)
Revised authorization 10/27/2022 CDER Memorandum (139 KB)
Updates to authorized labeling 11/3/2022 CDER Memorandum (89 KB)
Update to Authorization 11/30/2022 CDER Memorandum (197 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)
Updates to authorized labeling 6/29/2022 CDER Memorandum (389 KB)
Updates to authorized labeling 9/30/2022 CDER Memorandum (52 KB)
Revised authorization 10/27/2022 CDER Memorandum (139 KB)
Revised authorization 1/26/2023 CDER Memorandum (186 KB)

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)

EUA Action Action Date CDER Review Document
Original authorization 12/23/2021 CDER Review (7 MB)
Revised authorization 2/11/2022 CDER Memorandum (PDF - 948 KB)
Revised Authorization 3/23/2022 CDER Review (PDF - 928 KB)
Revised Authorization 8/5/2022 Clinical Virology Review (PDF - 2.09 MB)
Revised authorization 10/27/2022 CDER Memorandum (139 KB)
Revised authorization 2/1/2023 CDER Memorandum (358 KB)
Continuing Review 2/17/2023 CDER Memorandum (505 KB)
Revised Authorization 10/3/2023 CDER Memorandum (171 KB)

Paxlovid (Nirmatrelvir and Ritonavir)

EUA Action Action Date CDER Review Document
Original authorization 12/22/2021 CDER Review (4 MB)
Updates to authorized labeling 2/23/2022 CDER Review (28 KB)
Updates to authorized labeling 3/18/2022 CDER Review (274 KB)
Updates to authorized labeling 4/8/2022 CDER Clinical Pharmacology Review (117 KB)
Updates to authorized labeling 6/28/2022 CDER Memorandum (4 MB)
Revised Authorization 7/6/2022 CDER Review (27 KB)
Revised Authorization 8/5/2022 CDER Memorandum (PDF - 46 KB)
Updates to authorized labeling 8/25/2022 CDER Review (2 MB)
Updates to authorized labeling 9/26/2022 CDER Memorandum (49 KB)
Updates to authorized labeling 9/26/2022 Clinical Virology Review (699 KB)
Revised authorization 10/27/2022 CDER Memorandum (139 KB)
Revised authorization 2/1/2023 CDER Memorandum (56 KB)
Revised authorization 5/25/2023 CDER Memorandum (550 KB)
Revised authorization 11/1/2023 CDER Memorandum (40 KB)
Revised authorization 1/29/2024 CDER Memorandum (21 KB)
Revised authorization 3/12/2024 CDER Memorandum (133 KB)

Pemgarda (pemivibart)

EUA Action Action Date CDER Review Document
Original authorization 3/22/2024  CDER Review (8 MB)

Propofol-Lipuro 1%

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

REGEN-COV (Casirivimab and Imdevimab)

EUA Action Action Date CDER Review Document
Original authorization 11/21/2020 CDER Review (3 MB)
Revised authorization 2/03/2021 CDER Review (136 KB)
Revised authorization 2/25/2021 CDER Memorandum (52 KB)
Updates to authorized labeling 3/18/2021  CDER Revie​w (70 KB)
Updates to authorized labeling 5/14/2021 CDER Review (83 KB)
Revised authorization 6/3/2021 CDER Review​ (952.09 KB)
Revised authorization 7/30/2021 CDER Review (1.1 MB)
Updates to authorized labeling 8/17/2021 CDER Clinical Virology Review (382 KB)
Updates to authorized labeling 11/17/2021 CDER EUA Review (219 KB)
Updates to authorized labeling 12/22/2021 CDER Memorandum (88 KB)
Revised authorization 1/24/2022 CDER Memorandum (168 KB)

Sotrovimab

EUA Action Action Date CDER Review Document
Original authorization 5/26/2021 CDER Review (2 MB)
Updates to authorized labeling 7/9/2021 CDER Memorandum on Fact Sheet Update (128 KB)
Updates to authorized labeling 9/23/2021 CDER Memorandum on Fact Sheet Update (190 KB)
Updates to authorized labeling 11/1/2021 CDER Memorandum on Fact Sheet Update (162 KB)
Updates to authorized labeling 12/22/2021 CDER Memorandum on Fact Sheet Update (159 KB)
Revised authorization 2/23/2022 CDER Memorandum (891 KB)
Updates to authorized labeling 3/25/2022 CDER Memorandum (2 MB)

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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