FDA — authorised 20 October 2003
- Marketing authorisation holder: VIIV HLTHCARE
- Status: approved
🇺🇸 Lexiva in United States
FDA authorised Lexiva on 20 October 2003
Marketing authorisations
FDA — authorised 20 October 2003
- Application: NDA021548
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: LEXIVA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2007
- Application: NDA022116
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: LEXIVA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 April 2016
- Application: ANDA204060
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA204024
- Marketing authorisation holder: SUN PHARM
- Status: approved
Lexiva 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 Lexiva approved in United States?
Yes. FDA authorised it on 20 October 2003; FDA authorised it on 20 October 2003; FDA authorised it on 14 June 2007.
Who is the marketing authorisation holder for Lexiva in United States?
VIIV HLTHCARE holds the US marketing authorisation.