FDA — authorised 2 July 2003
- Application: NDA021500
- Marketing authorisation holder: GILEAD
- Local brand name: EMTRIVA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Emtriva in United States
FDA authorised Emtriva on 2 July 2003
Marketing authorisations
FDA — authorised 2 July 2003
- Marketing authorisation holder: GILEAD
- Status: approved
FDA — authorised 4 September 2018
- Application: ANDA203041
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 3 June 2019
- Application: ANDA206894
- Marketing authorisation holder: CIPLA
- Status: approved
FDA — authorised 4 June 2021
- Application: ANDA204131
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA208452
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 12 June 2025
- Application: ANDA090958
- Marketing authorisation holder: CIPLA
- Indication: Labeling
- Status: approved
The FDA approved Emtriva, manufactured by CIPLA, for its approved indication on 12 June 2025. This approval was granted through a standard expedited pathway. Emtriva is a medication used for its approved indication, as stated in its labelling.
Emtriva 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 Emtriva approved in United States?
Yes. FDA authorised it on 2 July 2003; FDA authorised it on 2 July 2003; FDA authorised it on 4 September 2018.
Who is the marketing authorisation holder for Emtriva in United States?
GILEAD holds the US marketing authorisation.