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 |
|---|---|---|---|---|
| 3/22/2024 | Pemgarda (220 KB) (reissued April 3, 2024 and August 26, 2024) Letter Granting EUA Amendment (May 17, 2024) (219 KB) Letter Granting EUA Amendment (September 26, 2024) (275 KB) | For emergency use for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg):
| Healthcare Providers (466 KB) (Updated September 26, 2024) Patients and Caregivers (192 KB) (Updated August 26, 2024) Frequently Asked Questions on the Emergency Use Authorization of Pemgarda (225 KB) (Updated September 26, 2024) | FRN EUA May 28, 2024 |
| 4/4/2023 | Gohibic (757 KB) (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 (2310 KB) Patients and Caregivers (950 KB) Frequently Asked Questions on the Emergency Use Authorization of Gohibic (141 KB) | FRN EUA |
| 11/08/2022 | Kineret (256 KB) | 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 |
| 12/23/2021 | Lagevrio (molnupiravir) (263 KB) (reissued November 15, 2023, August 5, October 27, 2022, February 1, 2023, and October 3, 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 (590 KB) (updated February 1, 2023, July 17, 2023, October 3, 2023 and June 18, 2024)
Patients, Parents, and Caregivers (136 KB) (updated February 1, 2023, October 3, 2023 and June 18, 2024)
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 (308 KB) (updated February 7, 2023) Prescriber Checklist for Lagevrio (181 KB) (updated February 1, 2023) | FRN EUA February 4, 2022 |
| 12/22/2021 | Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (215 KB) (reissued March 17, 2022, April 14, 2022, July 6, 2022, August 5, 2022, October 27, 2022, February 1, 2023, May 25, 2023, November 1, 2023, January 29, 2024, and March 13, 2024) 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)
| Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in 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. As of March 9, 2024, the presentation of Paxlovid in EUA packaging may not be dispensed. | Healthcare Providers (721 KB) (updated November 19, 2024) Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (310 KB) (updated September 12, 2024) Patients, Parents, and Caregivers (622 KB) (updated November 19, 2024) Dear Healthcare Provider Letter (343 KB) (updated March 13, 2024) Dosing Card for Healthcare Provider (1 MB) (updated March 13, 2024) Dosing Card for Patients, Parents, and Caregivers (2.6 MB) (updated March 13, 2024) Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (227 KB) (updated March 13, 2024) | FRN EUA February 4, 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) | FRN EUA August 5, 2021 |
| 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) | FRN EUA February 19, 2021 |
| 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) | FRN February 19, 2021 |
| 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) | FRN EUA September 11, 2020 |
| 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.
Related Resources
- EUAs issued for Vaccines
- EUAs issued for Medical Devices
- Guidance: Emergency Use Authorization of Medical Products and Related Authorities
- Healthcare Provider Fact Sheet Template
- Patient, Parent, and Caregiver Fact Sheet Template