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Important COVID-19 Outpatient Therapeutics Updates

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. Learn More >>

March 22, 2024: FDA issued emergency use authorization for Pemgarda (pemivibart), a monoclonal antibody authorized to help protect against COVID-19 Learn More >>

March 11, 2024: COVID-19 Treatments Locator Tool: Request to Health Care Providers Learn More >>

February 20, 2024: CMS Revised Letter: Introduction of Prescription Oral Antivirals for COVID-19 to the Commercial Market Learn More >>

January 29, 2024: FDA revises letter of authorization for the emergency use authorization for Paxlovid Learn More >>

December 20, 2023: Updates to the Sunsetting the US Government COVID-19 Therapeutics Distribution Program Learn More >>

December 20, 2023: Frequently Asked Questions About COVID-19 Therapeutics Transition to Commercial Distribution Learn More >>

December 14, 2023: The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) for bamlanivimab and etesevimab administered together Learn More >>

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. Learn More >>

November 14, 2023: Updates to the Sunsetting the US Government COVID-19 Therapeutics Distribution Program. Learn More >>

November 14, 2023: Frequently Asked Questions About COVID-19 Therapeutics Transition to Commercial Distribution. Learn More >>

October 27, 2023: Letter to COVID-19 therapeutics manufacturers, distributors, pharmacies and the health care payer community. Learn More >>

October 13, 2023: HHS and Pfizer Reach Agreement to Increase Patient Access to Paxlovid. Learn More >>

September 29, 2023: ASPR anticipates that the transition of Lagevrio from government-managed distribution to traditional commercial distribution will occur in November 2023. Learn More >>

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. Learn More >>

May 25, 2023: FDA Approves Paxlovid as the First Oral Antiviral for Treatment of COVID-19 in Adults. Learn More >>


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