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8 septiembre, 2022

Paxlovid Expiration Dates Extended

Expiration dates have been extended from 9 months after manufacture to 12 months for 4 lots of the COVID-19 antiviral therapy Paxlovid, which consists of copackaged nirmatrelvir tablets and ritonavir tablets.

The lot numbers and original expiration dates are listed on the FDA website. The nirmatrelvir-ritonavir lots were manufactured before the FDA issued an Emergency Use Authorization (EUA) for the product, which specified a 12-month shelf life rather than the 9 months initially specified by the manufacturer. To be eligible for the extension, the drugs must have been stored under conditions outlined by the FDA in the EUA fact sheet.

The expiration extensions are part of a broader program designed to preserve COVID-19 treatments that are in potentially short supply as data accrue supporting a longer safe shelf life. Previous actions include extensions from 18 months to 24 months for monoclonal antibodies tixagevimab copackaged with cilgavimab, or Evusheld; and from 12 months to 18 months for bebtelovimab, both of which are currently available under EUAs. Expiration dates on other treatments not currently authorized due to ineffectiveness against Omicron subvariants also have been extended in case they prove effective against future variants.

https://jamanetwork.com/journals/jama/fullarticle/2795911?guestAccessKey=53e01991-5e5c-448a-b3aa-2825b00e3d2f&utm_source=fbpage&utm_medium=social_jama&utm_term=7558286312&utm_campaign=article_alert&linkId=180281569&fbclid=IwAR2Xw0Me0lERSxk4rbNsSdpQ_P7i17l_l6W6OGv-t-DkSXTu5kUP1hDlgeA


Créditos: Comité científico Covid

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