FDA — authorised 25 May 2023
- Marketing authorisation holder: Pfizer, Inc.
- Status: approved
🇺🇸 Paxlovid (Copackaged) in United States
FDA authorised Paxlovid (Copackaged) on 25 May 2023
Marketing authorisations
FDA — authorised 19 November 2024
- Application: NDA217188
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
Paxlovid (Copackaged) is a medication developed by Pfizer. The FDA granted marketing authorisation for this product on 19 November 2024. The marketing authorisation holder is Pfizer, and the application number is NDA217188. The product was approved through the standard expedited pathway.
Paxlovid (Copackaged) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Paxlovid (Copackaged) approved in United States?
Yes. FDA authorised it on 25 May 2023; FDA authorised it on 19 November 2024.
Who is the marketing authorisation holder for Paxlovid (Copackaged) in United States?
Pfizer, Inc. holds the US marketing authorisation.