Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Learn more about Emergency Use Authorization.
FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact CDER's ability to authorize treatments for emergency use. Existing EUAs for products will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.
EUAs for CDER-regulated Products
| Date of First EUA Issuance | Most Recent Letter of Authorization (PDF) | Authorized Use 1 | Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) | Federal Register Notice for EUA |
|---|---|---|---|---|
| 4/4/2023 | Gohibic (757KB) (reissued April 12, 2023) | Gohibic is authorized for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). |
Healthcare Providers (2310KB) Patients and Caregivers (950KB) Frequently Asked Questions on the Emergency Use Authorization of Gohibic (141 KB) |
FRN EUA |
| 11/08/2022 | Kineret (256KB) | Kineret (anakinra) is authorized for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). |
Healthcare Providers (6560KB) Patients and Caregivers (4130KB) Frequently Asked Questions on the Emergency Use Authorization of Kineret (1750KB) |
FRN EUA March 13, 2023 |
| 02/11/2022 |
Bebtelovimab (460KB) (reissued August 5 and October 27, 2022) Letter Granting EUA Amendment (March 30, 2022) (216KB) Letter Granting EUA Amendment (September 16, 2022) (194KB) Letter Granting EUA Amendment (November 4, 2022) (310KB) FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region (November 30, 2022) ASPR and FDA Statement on Shelf-Life Extension of Bebtelovimab (October 28, 2022) |
Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. |
Healthcare Providers (763 KB) (updated November 4, 2022) Patients, Parents, and Caregivers (245KB)(updated November 4, 2022)
Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab (1 MB) |
|
| 12/23/2021 |
Lagevrio (molnupiravir) (286KB) (reissued August 5, October 27, 2022, and February 1, 2023) ASPR and FDA Statement on Shelf-Life Extension Evaluation of Lagevrio (October 21, 2022) |
Lagevrio is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in certain adults who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. |
Healthcare Providers (568 KB) (updated February 1, 2023 and July 17, 2023)
Patients, Parents, and Caregivers (142KB) (updated February 1, 2023)
COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR) Dear Healthcare Provider Letter (162 KB) (February 1, 2023) Dear Healthcare Provider Letter (268 KB) Frequently Asked Questions on the Emergency Use Authorization of Lagevrio (308KB) (updated February 7, 2023) Prescriber Checklist for Lagevrio (181KB) (updated February 1, 2023) |
|
| 12/22/2021 |
Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (306 KB) (reissued March 17, 2022, April 14, 2022, July 6, 2022, August 5, 2022, October 27, 2022, and February 1, 2023, and May 25, 2023) Letter Granting EUA Amendment (March 18, 2022) (161 KB) Letter Granting EUA Amendment (September 26, 2022) (255 KB) FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations (July 6, 2022) ASPR and FDA Statement on Shelf-Life Extension of Paxlovid (January 18, 2023) |
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. On May 25, 2023, Paxlovid was approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. |
Healthcare Providers (808 KB) (updated May 25, 2023) Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (323 KB) (updated May 25, 2023) Patients, Parents, and Caregivers (470 KB) (updated May 25, 2023) COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR) Dear Healthcare Provider Letter (593 KB) (updated August 5, 2022) Important Dispensing Information for Patients with Moderate Renal Impairment (476 KB) Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (292 KB) (updated September 14, 2023) |
|
| 12/08/2021 |
Evusheld (tixagevimab co-packaged with cilgavimab) (286KB) (reissued December 20, 2021, February 24, 2022, May 17, 2022, October 27, December 8, 2022, and January 26, 2023) FDA announces Evusheld is not currently authorized for emergency use in the U.S. (updated January 26, 2023) ASPR and FDA Statement on Shelf-Life Extension of Evusheld (December 5, 2022) Letter Granting EUA Amendment (June 29, 2022) (168KB) Letter Granting EUA Amendment (November 18, 2022) (197KB) Letter Granting EUA Amendment (December 21, 2022) (188KB) |
Evusheld is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to Evusheld. Therefore, Evusheld may not be administered for pre-exposure prophylaxis for prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. For emergency use as pre-exposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg): Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
|
Healthcare Providers (769 KB) (updated January 26, 2023)
Patients, Parents, and Caregivers (178KB) (updated January 26, 2023)
Dear Healthcare Provider Letter (135 KB) (January 26, 2023) Dear Healthcare Provider Letter (439 KB) (June 29, 2022)
Dear Healthcare Provider Letter (196 KB) (October 3, 2022) Updated EVUSHELD EUA Warnings and Precautions
Dear Healthcare Provider Letter (226 KB) (May 17, 2022) Dear Healthcare Provider Letter (144 KB) (March 22, 2022)
Frequently Asked Questions on the Emergency Use Authorization for Evusheld (942 KB) (updated October 20, 2022) |
|
| 06/24/2021 | Actemra (Tocilizumab) (249KB) (reissued December 21, 2022) |
For the treatment of COVID-19 in hospitalized pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). On December 21, 2022, Actemra was approved for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. |
Healthcare Providers (428 KB) (updated December 21, 2022) Patients, Parents, and Caregivers (136 KB) (updated December 21, 2022) Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (173 KB) (updated December 21, 2022) |
|
| 05/26/2021 |
Sotrovimab (375KB) (reissued October 8, 2021, December 16, 2021 and February 23, 2022) Letter Granting EUA Amendment (December 22, 2021) (161KB) FDA updates Sotrovimab emergency use authorization (April 5, 2022) ASPR and FDA Statement of additional Shelf-Life Extension of Strovimab (February 15, 2023) ASPR and FDA Statement on Shelf-Life Extension of Sotrovimab (August 3, 2022) Important updates about sotrovimab (ASPR) |
Sotrovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to sotrovimab. Therefore, sotrovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. |
Healthcare Providers (579 KB) (updated March 17, 2023)
Patients, Parents, and Caregivers (199 KB) (updated March 17, 2023)
Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (257 KB) (updated March 25, 2022) |
|
| 02/09/2021 |
Bamlanivimab and Etesevimab (900KB) (Reissued February 25, 2021, August 27, 2021, September 16, 2021, December 3, 2021, December 22, 2021 and January 24, 2022) ASPR and FDA Statement on Shelf-Life Extension of Bamlanivimab and Etesevimab (May 4, 2022) Important updates about bamlanivimab/etesevimab (ASPR) |
Bamlanivimab and etesevimab are not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bamlanivimab and etesevimab. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. |
Healthcare Providers (2 MB) (updated January 24, 2022) Patients, Parents, and Caregivers (157KB) (updated December 3, 2021)
Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (312 KB) (updated January 31, 2022) |
|
| 11/21/2020 |
REGEN-COV (Casirivimab and Imdevimab) (1.03MB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021, November 17, 2021 and January 24, 2022) ASPR and FDA Statement on Shelf-Life Extension of REGEN-COV (June 27, 2022) |
REGEN-COV (casirivimab and imdevimab) is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. Therefore, REGEN-COV may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. |
Healthcare Providers (2 MB) (updated January 24, 2022)
Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)
Dear Healthcare Provider Letter (435KB) (updated September 16, 2021) Statement on Post-Exposure Prophylaxis (July 30, 2021) Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated January 31, 2022) CDER Scientific Review Documents Supporting EUA Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021) |
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| 11/19/2020 | Baricitinib (Olumiant) (624KB) (Reissued May 10, 2022 and October 27, 2022) |
For emergency use by healthcare providers for the treatment COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). On May 10, 2022, Olumiant was approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. |
Healthcare Providers (Updated May 10, 2022) (272 KB) Patients, Parents, and Caregivers (Updated May 10, 2022) (128 KB) Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270 KB) (Updated May 10, 2022) |
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| 08/13/2020 | REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92 KB) | To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting | Healthcare Providers (108 KB) Patients and Caregivers (52 KB) REGIOCIT package insert for EUA (140 KB) |
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| 04/30/2020 | Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171 KB) 3 [also listed under Medical Device EUAs] |
To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic. |
Healthcare Providers (135 KB) Patients (125 KB) Instructions for Use, Bloodline/ Tubing (83 KB) Instructions for Use, UltraFlux (147 KB) Instructions for Use, multiFiltratePRO (15 MB) Summary of Product Characteristics (SmPC) (308 KB) Instructions for Use, MultiPlus (110 KB) |
|
| 04/11/2017 |
Atropine Auto-Injector (Rafa Laboratories Ltd.) Letter of Authorization (514 KB) Letter granting EUA amendment(s) (28 KB) 2nd letter granting EUA amendment(s) (33 KB) |
For the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). |
|
May 10, 2017 Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures |
1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved drugs used for their treatment. The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved drugs used for their treatment.
3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.