May 17, 2024: As HHS is no longer distributing COVID-19 therapeutics, except to certain federal entities, we ask that all providers finalize their reporting data in the Health Partner Ordering Portal (HPOP). If your organization or site received COVID-19 therapeutics from HHS, please reconcile that therapeutics inventory in HPOP, to the extent possible, by June 30.
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March 22, 2024: FDA issued emergency use authorization for Pemgarda (pemivibart), a monoclonal antibody authorized to help protect against COVID-19
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March 11, 2024: COVID-19 Treatments Locator Tool: Request to Health Care Providers
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February 20, 2024: CMS Revised Letter: Introduction of Prescription Oral Antivirals for COVID-19 to the Commercial Market
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January 29, 2024: FDA revises letter of authorization for the emergency use authorization for Paxlovid
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December 20, 2023: Updates to the Sunsetting the US Government COVID-19 Therapeutics Distribution Program
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December 20, 2023: Frequently Asked Questions About COVID-19 Therapeutics Transition to Commercial Distribution
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December 14, 2023: The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) for bamlanivimab and etesevimab administered together
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November 28, 2023: ASPR provides information about transition of Paxlovid to commercial distribution. Learn about ordering from the USG supply, returns, and patient coverage programs.
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November 14, 2023: Updates to the Sunsetting the US Government COVID-19 Therapeutics Distribution Program.
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November 14, 2023: Frequently Asked Questions About COVID-19 Therapeutics Transition to Commercial Distribution.
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October 27, 2023: Letter to COVID-19 therapeutics manufacturers, distributors, pharmacies and the health care payer community.
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October 13, 2023: HHS and Pfizer Reach Agreement to Increase Patient Access to Paxlovid.
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September 29, 2023: ASPR anticipates that the transition of Lagevrio from government-managed distribution to traditional commercial distribution will occur in November 2023.
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June 14, 2023: ASPR and the FDA authorize an additional extension to the shelf life for the Merck antiviral therapy Lagevrio (molnupiravir) capsules from 30 months to 36 months.
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May 25, 2023: FDA Approves Paxlovid as the First Oral Antiviral for Treatment of COVID-19 in Adults.
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Key Abbreviations
BARDA: Biomedical Advanced Research and Development Authority
CDC: Centers for Disease Control and Prevention
EUA: Emergency Use Authorization
FDA: U.S. Food and Drug Administration
HHS: U.S. Department of Health and Human Services
mAb: monoclonal antibody
NIH: National Institutes of Health