FDA — authorised 6 August 2007
- Application: NDA022128
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: SELZENTRY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Selzentry in United States
FDA authorised Selzentry on 6 August 2007
Marketing authorisations
FDA — authorised 6 August 2007
- Marketing authorisation holder: VIIV HLTHCARE
- Status: approved
FDA — authorised 4 November 2016
- Application: NDA208984
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: SELZENTRY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 February 2022
- Application: ANDA203347
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2023
- Application: ANDA217114
- Marketing authorisation holder: I 3 PHARMS
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2025
- Application: ANDA217880
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA216143
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA203382
- Marketing authorisation holder: SANDOZ INC
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
Selzentry 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 Selzentry approved in United States?
Yes. FDA authorised it on 6 August 2007; FDA authorised it on 6 August 2007; FDA authorised it on 4 November 2016.
Who is the marketing authorisation holder for Selzentry in United States?
VIIV HLTHCARE holds the US marketing authorisation.