Emergency Use Authorization--Archived Information
This page is intended to provide reference information on EUAs that were previously issued, and on amendments and revocations to EUAs.
Terminated or Revoked EUAs
The following EUAs are no longer in effect because they have been terminated or revoked.
- Coronavirus Disease 2019 (COVID-19) EUA - ARCHIVED INFORMATION
- Enterovirus D68 (EV-D68) EUA - ARCHIVED INFORMATION
- Zika Virus EUA - ARCHIVED INFORMATION
- Ebola Virus EUA - ARCHIVED INFORMATION
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA - ARCHIVED INFORMATION
- H1N1 EUAs - ARCHIVED INFORMATION
- Anthrax Vaccine Adsorbed (AVA) EUA - ARCHIVED INFORMATION
Some information may no longer be available. Please contact AskMCMi@fda.hhs.gov with questions.
Coronavirus Disease 2019 (COVID-19) EUA - ARCHIVED INFORMATION (Drug & Biological Products)
View current EUA information related to COVID-19, including a list of current EUAs.
Archived fact sheets for monovalent mRNA COVID-19 vaccines are available at: Coronavirus (COVID-19) | CBER-Regulated Biologics (drop-down section at bottom of page).
| Medical Product | Date of First EUA Issuance | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions/ Package Insert |
|---|---|---|---|
| Bebtelovimab | 2/11/2022 12/13/2024 |
December 13, 2024: On December 5, 2024, Lilly requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bebtelovimab since all lots of bebtelovimab manufactured and labeled for use under EUA 111 have expired. At the time of Lilly’s request, bebtelovimab was not authorized for use in geographic regions of the United States where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to bebtelovimab and regional variant frequency. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Evusheld (tixagevimab co-packaged with cilgavimab) | 12/08/2021 12/13/2024 |
December 13, 2024: On November 21, 2025, AstraZeneca requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) since all lots of Evusheld distributed under EUA 104 have expired. At the time of AstraZeneca’s request, Evusheld was not authorized for use in any region of the United States due to the national combined frequency of non-susceptible variants circulating in the United States being more than 90%, based on available information including variant susceptibility to Evusheld and national variant frequencies. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Sotrovimab | 05/26/2021 12/13/2024 |
December 13, 2024: On November 22, 2024, GSK requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for sotrovimab since all lots of sotrovimab manufactured and labeled for use under EUA 100 have expired. At the time of GSK’s request, sotrovimab was not authorized for use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility to sotrovimab and regional variant frequency. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| REGEN-COV (Casirivimab and Imdevimab) | 11/21/2020 12/13/2024 |
December 13, 2024: On November 25, 2024, Regeneron requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for REGEN-COV (Casirivimab and Imdevimab) since all lots of REGEN-COV manufactured and labeled for use under EUA 091 have expired and Regeneron does not intend to offer this product in the United States anymore. At the time of Regeneron’s request, REGEN-COV was not authorized for use in any region of the United States due to regional variant frequency and the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Bamlanivimab and Etesevimab | 02/09/2021 12/14/2023 |
December 14, 2023: On October 23, 2023, Lilly requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bamlanivimab and etesevimab administered together since all lots of bamlanivimab and etesevimab manufactured and labeled for use under EUA 094 have expired and that Lilly does not intend to offer this product in the United States anymore. At the time of Lilly’s request, bamlanivimab and etesevimab administered together was not authorized for use in any region of the United States due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bamlanivimab and etesevimab. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Janssen COVID-19 Vaccine | 02/27/2021 (issued) 06/01/2023 (revoked) |
On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the EUA of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA for this vaccine. Federal Register notices | |
| Fresenius Kabi Propoven 2% | 05/08/2020 (issued) 05/10/2022 (revoked) |
Fresenius Kabi notified FDA that it does not intend to offer the Fresenius Propoven 2% Emulsion in the United States anymore and requested FDA revoke the EUA for the Fresenius Propoven 2% Emulsion. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Propofol‐Lipuro 1% | 03/12/2021 (issued) 04/12/2023 (revoked) |
Braun Melsungen notified FDA that it does not intend to offer the Propofol-Lipuro 1% injectable emulsion in the United States anymore and requested FDA revoke the EUA for the Propofol-Lipuro 1% injectable emulsion. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Fresenius Kabi Propoven 2% | 05/08/2020 (issued) 05/10/2022 (revoked) |
Fresenius Kabi notified FDA that it does not intend to offer the Fresenius Propoven 2% Emulsion in the United States anymore and requested FDA revoke the EUA for the Fresenius Propoven 2% Emulsion. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Federal Register notices |
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| Remdesivir for Certain COVID-19 Patients | 05/01/2020 (issued) 08/28/2020 (reissued) 10/01/2020 (reissued) 10/22/2020 (reissued) 01/21/2022 (reissued) 04/25/2022 (revoked) |
As of April 25, 2022, Veklury (Remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) with positive results of direct SARS-CoV-2 viral testing, who are:
For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness Federal Register notices: |
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| Bamlanivimab | 11/09/2020 (issued) 04/16/2021 (revoked) |
April 16, 2021: Since the initial authorization of bamlanivimab administered alone for emergency use on November 9, 2020, there has been a sustained increase in SARS-CoV-2 viral variants across the U.S. that are resistant to bamlanivimab alone. Given the frequency of these particular viral variants, and since current testing technologies are not available to ascertain whether a particular patient who has tested positive for coronavirus disease 2019 (COVID-19) is infected with a viral variant prior to initiation of treatment, there is an increased risk of treatment failure when bamlanivimab is administered alone. Based on the totality of scientific evidence available, the Agency has concluded that the known and potential benefits of bamlanivimab administered alone no longer outweigh the known and potential risks for the product. Therefore, the Agency has determined that the criteria for issuance of an EUA are no longer met and has revoked EUA 90 for bamlanivimab administered alone for the treatment of COVID-19. Previously authorized use: For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Additional Information:
Federal Register notices: | |
| Chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19 | 03/28/2020 (issued) 06/15/2020 (revoked) | On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19. Previously Authorized Use: To only treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available or participation is not feasible. Federal Register notices:
| Chloroquine Phosphate Fact Sheet for Healthcare Providers (217KB)
Chloroquine Phosphate Fact Sheet for Patients (147KB)
Hydroxychloroquine Sulfate Fact Sheet for Healthcare Providers (206KB)
Hydroxychloroquine Sulfate Fact Sheet for Patients (148KB)
Frequently asked questions on the EUA for Chloroquine Phosphate and Hydroxychloroquine Sulfate (237KB) Hydroxychloroquine and Chloroquine drug safety communication about use for COVID-19 outside of a hospital setting or clinical trial |
Enterovirus D68 (EV-D68) EUA - ARCHIVED INFORMATION
For additional information, see Historical Information about Device Emergency Use Authorizations.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notices for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) | May 12, 2015 (issued) February 20, 2023 (terminated) | Authorization (PDF, 229 KB) | Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability (July 1, 2015) Termination of Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Enterovirus D68 (February 17, 2023) |
| Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) Termination of Declaration Authorizing Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 20, 2023)
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Zika Virus EUA - ARCHIVED INFORMATION
View current EUA information related to Zika virus, including a list of in vitro diagnostics currently authorized for emergency use.
| Medical Product | Date of EUA Issuance | Letter of Authorization or Other EUA-Related Information | EUA Determination and Declaration |
|---|---|---|---|
| LightMix Zika rRT-PCR Test (Roche Molecular Systems, Inc.) | August 26, 2016 (initial issuance) November 23, 2016 (amended) March 13, 2017 (revoked) | In response to Roche Molecular Systems Inc.’s request dated March 10, 2017 to withdraw the LightMix Zika rRT-PCR Test due to technical performance and business considerations, on March 13, 2017 FDA revoked the EUA for emergency use of the LightMix Zika rRT-PCR Test. As of March 13, 2017, the LightMix Zika rRT-PCR Test that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA. Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
| ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.) | August 17, 2016 (initial issuance) March 27, 2017 (amended) May 18, 2018 (amended) May 23, 2019 (revoked) | FDA granted the De Novo classification request (PDF, 175 KB) for InBios International, Inc.’s (“InBios”) ZIKV Detect 2.0 IgM Capture ELISA, and established a new classification regulation for Zika virus serological reagents (class II) in 21 CFR 866.3935 on May 23, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the InBios device, which was initially authorized for emergency use in 2016. Accordingly, on May 23, 2019, FDA determined that the criteria for issuance of an EUA under section 564(c) of the Act are no longer met and revoked the EUA for ZIKV Detect 2.0 IgM Capture ELISA, issued on August 17, 2016, and amended on March 27, 2017, and May 18, 2018, pursuant to section 564(g)(2) of the Act. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
| xMAP MultiFLEX Zika RNA Assay (Luminex Corporation) | August 4, 2016 (initial issuance) January 7, 2017 (amended) May 19, 2017 (amended) July 3, 2019 (revoked) | In a letter to FDA dated June 18, 2019, Luminex Corporation requested that the EUA for the xMAP MultiFLEX Zika RNA Assay issued on August 4, 2016, and amended on January 7, 2017, and May 19, 2017, be withdrawn. Luminex has decided to discontinue manufacture of the product and there is no remaining viable inventory of the xMAP MultiFLEX Zika RNA Assay. As a result, this product will no longer be marketed, and these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 3, 2019, FDA revoked the EUA for xMAP MultiFLEX Zika RNA Assay, pursuant to section 564(g)(2) of the Act. As of July 3, 2019, the xMAP MultiFLEX Zika RNA Assay that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA. Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
| ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.) | September 18, 2017 (initial issuance) November 16, 2017 (amended) April 18, 2019 (amended) July 17, 2019 (revoked) | Siemens Healthcare Diagnostics Inc.’s (“Siemens”) ADVIA Centaur Zika test (K191578) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name “Zika virus serological reagents,” on July 17, 2019. FDA has concluded “that this is an adequate, approved, and available alternative for the Siemens device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act.” In the context of section 564, the term “approved” refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on July 17, 2019, FDA determined that the criteria for issuance of an EUA under section 564(c) of the Act are no longer met and revoked the EUA for ADVIA Centaur Zika test, issued on September 18, 2017, and amended on November 16, 2017, and April 18, 2019, pursuant to section 564(g)(2) of the Act. Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
| LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated) | April 5, 2017 (initial issuance) November 6, 2017 (amended) December 27, 2018 (amended) October 28, 2019 (revoked) | DiaSorin Inc.’s (“DiaSorin’s”) LIAISON XL Zika Capture IgM II assay (K192046) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name “Zika virus serological reagents,” on October 28, 2019. FDA has concluded that this is an adequate, approved, and available alternative for DiaSorin’s device which was initially authorized for emergency use in 2017, for purposes of section 564(c)(3) of the Federal Food, Drug and Cosmetic Act (the Act)”. As used in section 564(c)(3), the term “approved” refers to a product that is approved, authorized, licensed, or cleared under section 505, 510(k), 513, or 515 of the Act or section 351 of the Public Health Service Act. Accordingly, on October 28, 2019, FDA determined that the criteria for issuance of the Emergency Use Authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for LIAISON XL Zika Capture IgM II assay, issued on April 5, 2017, and amended on November 6, 2017, and December 27, 2018, pursuant to section 564(g)(2) of the Act. Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
| DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.) | September 27, 2017 (initial issuance) February 6, 2018 (amended) August 3, 2018 (amended) June 3, 2020 (revoked) | Chembio Diagnostic Systems, Inc.’s (“Chembio”) DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name “Zika virus serological reagents,” on June 3, 2020. FDA has concluded “that this is an adequate, approved, and available alternative for the Chembio device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act.” Accordingly, on June 3, 2020, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for DPP Zika IgM Assay System, issued on September 27, 2017, and amended on February 6, 2018, and August 3, 2018, pursuant to section 564(g)(2) of the Act. Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling Federal Register (FR) notices: | Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) (still in effect) |
Ebola Virus EUA – ARCHIVED INFORMATION
View current EUA information related to Ebola.
| Medical Product | Date of EUA Issuance | Letter of Authorization or Other EUA-Related Information | EUA Determination and Declaration |
|---|---|---|---|
| In vitro diagnostics | Various | Historical information about Ebola virus IVDs 2014-2016 including letters of authorization, fact sheets, and labeling FR notices:
| Declaration (still in effect) |
| ReEBOV Antigen Rapid Test (Zalgen Labs, LLC) | February 24, 2015 (initial issuance)
March 16, 2015 (reissuance) November 3, 2016 (reissuance) May 18, 2019 (revoked) | On May 18, 2018, FDA revoked the EUA for emergency use of the ReEBOV Antigen Rapid Test, which was authorized by FDA for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). On February 24, 2015, based on a request by Corgenix Inc. (“Corgenix”), FDA issued a letter authorizing the emergency use of this test. On November 3, 2016, FDA reissued the EUA to allow Zalgen Labs, LLC (“Zalgen”) (and its authorized distributors) to distribute the ReEBOV Antigen Rapid Test manufactured by Corgenix , as well as distribute the ReEBOV Antigen Rapid Test manufactured by Zalgen if it met certain conditions, including that FDA concur after receiving performance characteristics for the Zalgen manufactured ReEBOV Antigen Rapid Test. In a letter to FDA dated March 1, 2018, Zalgen requested to FDA that the transfer of the EUA from Corgenix be withdrawn. In addition, there is no remaining viable inventory of the ReEBOV Antigen Rapid Test manufactured by Corgenix. As a result, this product will no longer be made available. These circumstances make revocation of the EUA appropriate to protect the public health or safety. Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus (Federal Register notice, August 2, 2018) Historical information about Ebola virus IVDs including letters of authorization, fact sheets, and labeling Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus (Federal Register notice, June 5, 2015)
| Declaration (still in effect) |
OraQuick Ebola Rapid Antigen Test - for use with whole blood (OraSure Technologies, Inc.) and OraQuick Ebola Rapid Antigen Test - for use with cadaveric oral fluid (OraSure Technologies, Inc.) | Whole blood January 30, 2019 (amended) October 10, 2019 (revoked) Cadaveric oral fluid September 26, 2016 (reissuance) February 1, 2019 (amended) October 10, 2019 (revoked) | FDA granted the De Novo classification request (PDF, 355 KB) for OraSure Technologies Inc.’s (“OraSure’s”) OraQuick Ebola Rapid Antigen Test, and established a new classification regulation for “Device to detect antigens of biothreat microbial agents in human clinical specimens” (class II) in 21 CFR 866.4002 on October 10, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the OraSure devices which were initially authorized for emergency use in 2015, for use with whole blood specimens and 2016, for cadaveric oral fluid. Accordingly, on October 10, 2019, FDA determined that the criteria for issuance of both Emergency Use Authorizations (EUAs) under section 564(c) of the Federal Food, Drug and Cosmetic Act (the Act) are no longer met and revoked the EUAs for: (1) OraQuick Ebola Rapid Antigen Test for use with whole blood specimens issued on July 31, 2015, and amended on March 18, 2016, and January 30, 2019, and (2) OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid issued on March 4, 2016, and amended on November 14, 2016, and February 1, 2019, pursuant to section 564(g)(2) of the Act. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens Historical information about Ebola virus IVDs including letters of authorization, fact sheets, and labeling Federal Register notices:
| Declaration (still in effect) |
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA – ARCHIVED INFORMATION
View current EUA information related to MERS-CoV. MERS-CoV EUAs in the list below have been reissued, and have current counterparts.
| Medical Product | Date of EUA Issuance | Letter of Authorization or Other EUA-Related Information | EUA Determination and Declaration | PREP Act Declaration (if applicable) |
|---|---|---|---|---|
| CDC Novel Coronavirus 2012 Real-time RT-PCR Assay | June 5, 2013 (Note: This EUA was reissued in its entirety on June 10, 2014 – current EUA) | Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus (FR notice, July 17, 2013 ) | Determination and Declaration – HHS (still in effect) | (see Determination) |
| RealStar MERS-CoV RT-PCR Kit U.S. | July 17, 2015 (Note: This EUA was reissued in its entirety on February 12, 2016 – current EUA) | Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus (FR notice, September 1, 2015 ) | Determination and Declaration – HHS (still in effect) | (see Determination) |
H1N1 EUAs - ARCHIVED INFORMATION
There are no current EUAs for H1N1.
| Medical Product | Date of EUA Issuance | Letter of Authorization or Other EUA-Related Information | EUA Determination and Declaration |
|---|---|---|---|
| Antiviral Disposition: Oseltamivir (Tamiflu), Zanamivir (Relenza), and Peramivir | June 22, 2010 | Authorization Disposition Letter and Question and Answer Attachment (June 22, 2010 - ARCHIVED) Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments (June 22, 2010 - ARCHIVED) | Declaration of Emergency Pursuant to Section 564 of the FD&C Act and Renewal of Determination that a Public Health Emergency Exists (March 26, 2010) (PDF, 151 KB - ARCHIVED) |
| Antivirals | Various | Peramivir Tamiflu Relenza | (see above) |
| In vitro diagnostics | Various | Historical information about 2009 H1N1 Influenza EUAs for IVDs including letters of authorization, fact sheets, and labeling | (see above) |
| Personal Protective Equipment (PPE) | May 1, 2009 | Historical information about 2009 H1N1 Influenza EUAs for PPE including letters of authorization and fact sheets | (see above) |
Anthrax Vaccine Adsorbed (AVA) EUA - ARCHIVED INFORMATION
There are no current EUAs for Anthrax Vaccine Adsorbed (AVA); also see information about AVA approval. Note that current anthrax-related EUAs are in place for doxycycline mass dispensing and National Postal Model Anthrax EUA.
| Medical Product | Date of EUA Issuance | Letter of Authorization or Other EUA-Related Information | EUA Determination and Declaration | PREP Act Declaration (if applicable) |
|---|---|---|---|---|
| AVA | January 14, 2005 | Extension (FR notice, August 3, 2005) Termination (FR notice, February 1, 2006) | Determination and Declaration Regarding Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax (FR notice, February 2, 2005) | Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax (FR notice, February 2, 2005) |
Related Links
- Summary of Process for EUA Issuance
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- Public Readiness and Emergency Preparedness (PREP) Act
- HHS Public Health Emergency Information
- HHS Public Health Emergency EUA Authorization Declarations
Anthrax: Doxycycline Mass Dispensing EUA Information
The 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) together replace the need for the doxycycline mass dispensing EUA (issued on July 21, 2011). Therefore, the doxycycline emergency dispensing order and EUI should be used by stakeholders for anthrax preparedness and response instead of the mass dispensing EUA. The July 21, 2011, mass dispensing EUA, and the October 14, 2011, National Postal Model anthrax EUA will be terminated by FDA, and notice of such termination will be published in the Federal Register.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax (“Doxycycline mass dispensing EUA”) | July 21, 2011 | 2011 Letter of Authorization (PDF, 9.0 MB) | Authorization of Emergency Use of Oral Formulations of Doxycycline (August 4, 2011)
| Stakeholders should refer to the 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) for current anthrax preparedness information. | Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information (July 20, 2012) Renewal of Declaration on Emergency Use of Doxycycline (July 20, 2011) | Anthrax Medical Countermeasures-Amendment (The amendment of the October 1, 2008, declaration is effective as of January 1, 2016.) |
Anthrax: National Postal Model Anthrax EUA Information
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax | October 14, 2011
(originally issued on October 6, 2008, with subsequent amendments) | Amendment to the Letter of Authorization (October 14, 2011) (PDF, 7 MB)
Amendment to the Letter of Authorization (February 25, 2009) (PDF, 97 KB) |
| Stakeholders should refer to the 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) for current anthrax preparedness information. | Renewal of Declaration ... (July 20, 2012) Renewal of Declaration ... (July 20, 2011) Renewal of Declaration ... (October 1, 2010) Renewal of Declaration ... (October 1, 2009) Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information – Federal Register (October 1, 2008) | Anthrax Medical Countermeasures-Amendment (The amendment of the October 1, 2008, declaration is effective as of January 1, 2016.)
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