FDA — authorised 23 June 2006
- Marketing authorisation holder: JANSSEN PRODS
- Status: approved
🇺🇸 Prezista in United States
FDA authorised Prezista on 23 June 2006
Marketing authorisations
FDA — authorised 7 March 2008
- Application: NDA021976
- Marketing authorisation holder: JANSSEN PRODS
- Indication: Labeling
- Status: approved
FDA — authorised 7 September 2018
- Application: NDA205395
- Marketing authorisation holder: JANSSEN PRODS
- Indication: Labeling
- Status: approved
FDA — authorised 19 November 2023
- Application: ANDA202073
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA215389
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA211578
- Marketing authorisation holder: DR REDDYS
- Status: approved
Prezista 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 Prezista approved in United States?
Yes. FDA authorised it on 23 June 2006; FDA authorised it on 7 March 2008; FDA authorised it on 7 September 2018.
Who is the marketing authorisation holder for Prezista in United States?
JANSSEN PRODS holds the US marketing authorisation.