FDA — authorised 20 September 2002
- Application: NDA021449
- Marketing authorisation holder: GILEAD
- Local brand name: HEPSERA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Hepsera in United States
FDA authorised Hepsera on 20 September 2002
Marketing authorisations
FDA — authorised 29 August 2013
- Application: ANDA202051
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Indication: Not Applicable
- Status: approved
FDA — authorised 6 July 2018
- Application: ANDA205459
- Marketing authorisation holder: APOTEX
- Status: approved
Hepsera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Hepsera approved in United States?
Yes. FDA authorised it on 20 September 2002; FDA authorised it on 29 August 2013; FDA authorised it on 6 July 2018.
Who is the marketing authorisation holder for Hepsera in United States?
GILEAD holds the US marketing authorisation.