FDA — authorised 17 November 1995
- Marketing authorisation holder: VIIV HLTHCARE
- Status: approved
🇺🇸 Epivir in United States
FDA authorised Epivir on 17 November 1995
Marketing authorisations
FDA — authorised 31 December 2015
- Application: ANDA091606
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
FDA — authorised 26 September 2019
- Application: ANDA077464
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 25 July 2022
- Application: ANDA216332
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 7 October 2022
- Application: NDA215413
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 29 October 2025
- Application: NDA210807
- Marketing authorisation holder: MSD MERCK CO
- Indication: Labeling
- Status: approved
The FDA approved Epivir, manufactured by MSD Merck Co, through a standard expedited pathway. The approval date was October 29, 2025, with application number NDA210807. The approved indication for Epivir is listed in its labeling.
Epivir 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 Epivir approved in United States?
Yes. FDA authorised it on 17 November 1995; FDA authorised it on 31 December 2015; FDA authorised it on 26 September 2019.
Who is the marketing authorisation holder for Epivir in United States?
VIIV HLTHCARE holds the US marketing authorisation.