FDA — authorised 5 May 2003
- Application: NDA021399
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: IRESSA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Iressa in United States
FDA authorised Iressa on 5 May 2003
Marketing authorisations
FDA — authorised 13 July 2015
- Application: NDA206995
- Marketing authorisation holder: ASTRAZENECA
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 23 September 2022
- Application: ANDA209532
- Marketing authorisation holder: APOTEX
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2023
- Application: ANDA211591
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA208913
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2023
- Application: ANDA212827
- Marketing authorisation holder: NATCO
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2025
- Application: ANDA211826
- Marketing authorisation holder: CIPLA
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
Iressa 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 Iressa approved in United States?
Yes. FDA authorised it on 5 May 2003; FDA authorised it on 13 July 2015; FDA authorised it on 23 September 2022.
Who is the marketing authorisation holder for Iressa in United States?
ASTRAZENECA holds the US marketing authorisation.