FDA — authorised 7 May 2007
- Application: NDA020978
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
🇺🇸 Ziagen in United States
FDA authorised Ziagen on 7 May 2007
Marketing authorisations
FDA — authorised 18 June 2012
- Application: ANDA091294
- Marketing authorisation holder: MYLAN PHARMS INC
- Status: approved
FDA — authorised 26 September 2016
- Application: ANDA201107
- Marketing authorisation holder: HETERO LABS LTD III
- Indication: Labeling
- Status: approved
FDA — authorised 21 November 2017
- Application: ANDA078119
- Marketing authorisation holder: CIPLA
- Status: approved
FDA — authorised 7 October 2022
- Application: NDA215413
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
Ziagen 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 Ziagen approved in United States?
Yes. FDA authorised it on 7 May 2007; FDA authorised it on 18 June 2012; FDA authorised it on 26 September 2016.
Who is the marketing authorisation holder for Ziagen in United States?
VIIV HLTHCARE holds the US marketing authorisation.