FDA — authorised 18 November 2004
- Marketing authorisation holder: OSI PHARMS
- Status: approved
🇺🇸 Tarceva in United States
FDA authorised Tarceva on 18 November 2004
Marketing authorisations
FDA — authorised 18 November 2004
- Application: NDA021743
- Marketing authorisation holder: OSI PHARMS
- Local brand name: TARCEVA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2015
- Application: ANDA091059
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 5 November 2019
- Application: ANDA211960
- Marketing authorisation holder: SHILPA
- Status: approved
FDA — authorised 16 April 2020
- Application: ANDA213065
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 22 June 2022
- Application: ANDA216342
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 24 May 2024
- Application: ANDA209267
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
Tarceva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Tarceva approved in United States?
Yes. FDA authorised it on 18 November 2004; FDA authorised it on 18 November 2004; FDA authorised it on 28 August 2015.
Who is the marketing authorisation holder for Tarceva in United States?
OSI PHARMS holds the US marketing authorisation.