FDA — authorised 25 May 2023
- Application: NDA217188
- Marketing authorisation holder: PFIZER
- Local brand name: PAXLOVID (COPACKAGED)
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Paxlovid (Copackaged) in United States
FDA authorised Paxlovid (Copackaged) on 25 May 2023
Marketing authorisation
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.
Who is the marketing authorisation holder for Paxlovid (Copackaged) in United States?
PFIZER holds the US marketing authorisation.