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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)

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)

Baricitinib (Olumiant) in Combination with remdesivir (Veklury)

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)

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)

Sotrovimab

EUA Action Action Date CDER Review Document
Original authorization 5/26/2021 CDER Review (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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