FDA — authorised 26 April 2023
- Application: ANDA208913
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: GEFITINIB
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 EGFR-TK Inhibitor in United States
FDA authorised EGFR-TK Inhibitor on 26 April 2023 · 1 US adverse-event reports
Marketing authorisations
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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 23 April 2025 – 23 April 2026
- Total reports: 1
Most-reported reactions
- Interstitial Lung Disease — 1 report (100%)
Other Oncology approved in United States
Frequently asked questions
Is EGFR-TK Inhibitor approved in United States?
Yes. FDA authorised it on 26 April 2023; FDA authorised it on 31 May 2023; FDA authorised it on 16 May 2025.
Who is the marketing authorisation holder for EGFR-TK Inhibitor in United States?
ACTAVIS LABS FL INC holds the US marketing authorisation.