Treats metastatic non-small cell lung cancer (NSCLC). NDA 206995, held by Astrazeneca. Gefitinib.
As of Nov 13, 2026, NDA 206995 (Iressa), held by Astrazeneca, was first approved by FDA on Jul 13, 2015, with 2 approved supplements and 0 published complete response letters.
IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Iressa250MG · tablet;oral | Gefitinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Aug 22, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Jul 13, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
