General Medicine

FDA Extends Shelf-Life of Certain Lots of COVID-19 Antiviral Paxlovid

Avatar photoBrian Park, PharmD
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The extended shelf-life of Paxlovid is authorized for 4 lots that were manufactured with a 9-month expiry prior to the issuance of Emergency Use Authorization.

The Food and Drug Administration (FDA) has authorized a 3-month extension to the shelf-life of 4 lots of Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) that were manufactured prior to the issuance of Emergency Use Authorization (EUA) and labeled with a 9-month expiry.

The following lots reflect the 12-month shelf-life of Paxlovid, when stored at controlled room temperature 20○C to 25○C (68○F to 77○F); excursions permitted between 15○C to 30○C (59○F to 86○F):

  • Co-Pack Lot Number FL4516; Labeled Co-Pack Expiration Date 7/31/22; Extended Co-Pack Expiration Date 10/31/22
  • Co-Pack Lot Number FL4517; Labeled Co-Pack Expiration Date 7/31/22; Extended Co-Pack Expiration Date 10/31/22
  • Co-Pack Lot Number FR7229; Labeled Co-Pack Expiration Date 7/31/22; Extended Co-Pack Expiration Date 10/31/22
  • Co-Pack Lot Number FR9088; Labeled Co-Pack Expiration Date 8/31/22; Extended Co-Pack Expiration Date 11/31/22

Paxlovid is authorized for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40 kg with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is supplied in 2 different dose packs:

  • 300 mg nirmatrelvir; 100 mg ritonavir: each carton contains 30 tablets divided in 5 daily-dose blister cards; each daily blister card contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each).
  • 150 mg nirmatrelvir; 100 mg ritonavir: each carton contains 20 tablets divided in 5 daily-dose blister cards; each daily blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each).

Reference

US Food and Drug Administration. Expiration dating extension. Accessed July 26, 2022. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension

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This article originally appeared on MPR