Pemgarda (220 KB) (reissued April 3, 2024 and August 26, 2024)
Letter Granting EUA Amendment (May 17, 2024) (219 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):
- 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:
- who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
Healthcare Providers (466 KB) (Updated August 26, 2024)
Patients and Caregivers (192 KB) (Updated August 26, 2024)
Frequently Asked Questions on the Emergency Use Authorization of Pemgarda (235 KB) (Updated August 26, 2024)
Healthcare Providers (2310 KB)
Patients and Caregivers (950 KB)
Frequently Asked Questions on the Emergency Use Authorization of Gohibic (141 KB)
Healthcare Providers (6560KB)
Patients and Caregivers (4130KB)
Frequently Asked Questions on the Emergency Use Authorization of Kineret (1750KB)
Bebtelovimab (460 KB) (reissued August 5 and October 27, 2022)
Letter Granting EUA Amendment (March 30, 2022) (216 KB)
Letter Granting EUA Amendment (September 16, 2022) (194 KB)
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 (245 KB)(updated November 4, 2022)
Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab (1 MB)
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)
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)
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 (711 KB) (updated September 12, 2024)
Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (310 KB) (updated September 12, 2024)
Patients, Parents, and Caregivers (693 KB) (updated March 13, 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)
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
- Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
- For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Healthcare Providers (769 KB) (updated January 26, 2023)
- Spanish (1 MB) (updated December 21, 2022)
Patients, Parents, and Caregivers (178KB) (updated January 26, 2023)
- Spanish (342KB) (updated October 3, 2022)
Dear Healthcare Provider Letter (135 KB) (January 26, 2023)
Dear Healthcare Provider Letter (439 KB) (June 29, 2022)
New Repeat Dosage Recommendations
Dear Healthcare Provider Letter (196 KB) (October 3, 2022) Updated EVUSHELD EUA Warnings and Precautions
Dear Healthcare Provider Letter (226 KB) (May 17, 2022)
Addition of EVUSHELD EUA Warning and Precaution for Risk of Cross-Hypersensitivity with COVID-19 Vaccines
Dear Healthcare Provider Letter (144 KB) (March 22, 2022)
Updated EVUSHELD EUA Dosage Recommendations for Patients Who Received an Initial Dose of 150 mg tixagevimab and 150 mg cilgavimab
Frequently Asked Questions on the Emergency Use Authorization for Evusheld (942 KB) (updated October 20, 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)
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)
- Spanish (426KB) (updated April 28, 2023)
Patients, Parents, and Caregivers (199 KB) (updated March 17, 2023)
- Spanish (178KB) (updated April 28, 2023)
Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (257 KB) (updated March 25, 2022)
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)
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)
Patients and Caregivers (52 KB)
REGIOCIT package insert for EUA (140 KB)
[also listed under Medical Device EUAs]
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)
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)
May 10, 2017 Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures
