FDA — authorised 5 November 2015
- Marketing authorisation holder: GILEAD SCIENCES INC
- Status: approved
🇺🇸 Vemlidy in United States
FDA authorised Vemlidy on 5 November 2015
Marketing authorisations
FDA — authorised 10 November 2016
- Application: NDA208464
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: VEMLIDY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2017
- Application: NDA208351
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Labeling
- Status: approved
FDA — authorised 18 March 2019
- Application: NDA207561
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Labeling
- Status: approved
FDA — authorised 30 March 2023
- Application: ANDA214226
- Marketing authorisation holder: LUPIN
- Local brand name: TENOFOVIR ALAFENAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2024
- Application: NDA210251
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Efficacy
- Status: approved
GILEAD SCIENCES INC received marketing authorisation for Vemlidy from the FDA on 2024-02-23. The approval was granted under the standard expedited pathway for NDA210251. Vemlidy is indicated for its efficacy in treating a specific condition.
FDA — authorised 20 June 2025
- Application: NDA208215
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Efficacy
- Status: approved
The FDA approved Vemlidy, a drug for the treatment of chronic hepatitis B infection, on 20 June 2025. The approval was granted to Gilead Sciences Inc, the marketing authorisation holder. This approval was made under the standard expedited pathway.
FDA
- Application: ANDA214072
- Marketing authorisation holder: SHILPA MEDICARE LTD
- Local brand name: TENOFOVIR ALAFENAMIDE
- Indication: TABLET — ORAL
- Status: approved
Vemlidy 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 Vemlidy approved in United States?
Yes. FDA authorised it on 5 November 2015; FDA authorised it on 10 November 2016; FDA authorised it on 7 April 2017.
Who is the marketing authorisation holder for Vemlidy in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.