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Bebtelovimab - bebtelovimab injection, solution-Eli Lilly and Company
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd8dc07c-3aae-4cc2-a547-3a19357411ca

Aug 5th, 2022 - SPL UNCLASSIFIED SECTION HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use BEBTELOVIMAB under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for BEBTELOVIMAB. BEBTELOVIMAB injection for intravenous use Original EUA Authorized Date: 02/2022 Revised EUA Authorized Date: 08/2022 ----------------------------RECENT...

Pfizer-biontech covid-19 vaccine, bivalent - bnt162b2 original and omicron ba.4/ba.5 injection, suspension-Pfizer Manufacturing Belgium NV
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6da3019-5c22-42a7-9e55-dc2e6d3ccc2d

Aug 4th, 2022 - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pfizer-BioNTech COVID-19 Vaccine, Bivalent Original and Omicron BA.4/BA.5 DO NOT DILUTE Age 12y & older Vial contains 6 doses of 0.3 mL For intramuscular use. Contains no preservative. For use under Emergency Use Authorization. After first use store at 2 to 25°C (35 to 77°F) and discard after 12 hours. First use date and time: NDC 59267-0304-1 PRINCIPAL DIS...

Novavax covid-19 vaccine, adjuvanted - nvx-cov2373 injection, suspension-Novavax, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b237fbc-d58a-4ca0-a56b-f9425d14dab5

Jul 26th, 2022 - SPL UNCLASSIFIED SECTION The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Novavax COVID-19 Vaccine, Adjuvanted, for active immunization to prevent COVID-19 in individuals 18 years of age and older. SPL UNCLASSIFIED SECTION Vaccination providers enrolled in the federal COVID-19 Vaccination Program...

Paxlovid - nirmatrelvir and ritonavir kit-Pfizer Laboratories Div Pfizer Inc
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bdddfba-bd31-44cb-ba9e-23a4e17a4691

Jul 11th, 2022 - The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV...

Evusheld - azd7442 kit-AstraZeneca Pharmaceuticals LP
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=168dad7e-9b75-4780-8c8c-34e164de0733

Jun 29th, 2022 - SPL UNCLASSIFIED SECTION HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use EVUSHELD™ under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for EVUSHELD. EVUSHELD (tixagevimab) injection; (cilgavimab) injection, co-packaged for intramuscular use Original EUA Authorized Date: 12/2021 -----------RECENT MAJOR CHANG...

Moderna covid-19 vaccine - cx-024414 injection, suspension-Moderna US, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6445f65-cdf7-4a8f-9981-88ab41c0246f

Jun 17th, 2022 - SPL UNCLASSIFIED SECTION PRIMARY SERIES PRESENTATION 6 months through 5 years of age The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. This Fact Sheet pertains only to Moderna COVID-19 Vac...

Moderna covid-19 vaccine - cx-024414 injection, suspension-Moderna US, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a7ad7e4-1d42-46a2-9696-d52119871a9e

Jun 17th, 2022 - SPL UNCLASSIFIED SECTION BOOSTER DOSE ONLY PRESENTATION FOR 18 YEARS OF AGE AND OLDER Another presentation of Moderna COVID-19 Vaccine supplied in multiple-dose vials with a red cap and labels with a light blue border can be used for a booster dose for individuals 18 years of age and older. The Moderna COVID-19 Vaccine supplied in multiple-dose vials with a red cap and labels with a light blue ...

Lagevrio - molnupiravir capsule-Merck Sharp & Dohme LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b0da643-ab23-4a0b-a9ec-a434522446d0

May 23rd, 2022 - SPL UNCLASSIFIED SECTION FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR LAGEVRIO™ (molnupiravir) CAPSULES HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use LAGEVRIO under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for LAGEVRIO. LAGEVRIO™ (molnupiravir) capsules, for oral use Original ...

FDA updates Sotrovimab emergency use authorization
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization
US Food and Drug Administration (FDA)

Apr 5th, 2022 - Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant

U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
https://www.gene.com/media/press-releases/14948/2022-04-03/us-fda-grants-priority-review-to-genente
Genentech

Apr 3rd, 2022 - If approved, Actemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide Actemra was previously granted Emergency Use Authorization for the treatment of COVID-19 in hospitalized adults and children

Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of Bebtelovimab for Coronavirus Disease 2019 (COVID-19)
http://pi.lilly.com/eua/bebtelovimab-eua-factsheet-patient.pdf
Eli Lilly and Company

Feb 11th, 2022 - You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you or your child with bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2...

Lilly will supply up to 600,000 doses of bebtelovimab to U.S. government in ongoing effort to provide COVID-19 treatment options
https://investor.lilly.com/news-releases/news-release-details/lilly-will-supply-600000-doses-bebtelovimab-us-government
Eli Lilly and Company

Feb 10th, 2022 - Bebtelovimab neutralizes Omicron as demonstrated by pseudovirus and authentic virus data Patients will continue to have no out-of-pocket costs for the medication

Janssen covid-19 vaccine - ad26.cov2.s injection, suspension-Janssen Products, LP
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14a822ff-f353-49f9-a7f2-21424b201e3b

Feb 2nd, 2022 - Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Veklury - remdesivir injection-Gilead Sciences, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98b7e6bf-2668-4a61-a874-194eb674b15c

Jan 27th, 2022 - HEALTH CARE PROVIDER LETTER SECTION IMPORTANT PRESCRIBING INFORMATION Subject: Updated Emergency Use Authorization (EUA) for treatment of coronavirus disease 2019 (COVID-19) in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ...

Veklury - remdesivir injection-Gilead Sciences, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0978fa8-53ff-4ca2-82a7-567fd3e958ca

Jan 27th, 2022 - VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are [see Clinical Studies (14)]: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high...

Casirivimab - casirivimab injection, solution, concentrate-Regeneron Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5bf7a31-7e17-4a94-805c-d231ea458fb0

Jan 24th, 2022 - REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult 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 a...

Resp homo - human coronavirus (rna) liquid-Deseret Biologicals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f437b94-ce56-41fe-9157-4f19c5dfe5cb

Jan 18th, 2022 - For the temporary relief of symptoms such as runny nose, cough, and fever.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Acst kit (antibody covid-19 screening test kit) - isopropyl alcohol kit-Asclemed USA, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=918e29ec-20fa-4e45-9f93-7bde16d5cac0

Jan 14th, 2022 - Uses For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injectionPurpose: Antiseptic