Quick answers
- What is Gefitinib used for?
- The FDA-approved label (Iressa, AstraZeneca Pharmaceuticals LP, February 28, 2023) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gefitinib have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Gefitinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gefitinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gefitinib?
- 5 companies list prescription products of Gefitinib in the FDA NDC Directory, including Natco Pharma USA LLC, Teva Pharmaceuticals, Inc. and Qilu Pharmaceutical Co., Ltd..
What Gefitinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Iressa, AstraZeneca Pharmaceuticals LP, effective February 28, 2023. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, coated · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Iressa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Natco Pharma USA LLC1 product
- Teva Pharmaceuticals, Inc.1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- AstraZeneca Pharmaceuticals LP1 product
- Ingenus Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206995 IRESSA | Astrazeneca | July 13, 2015 | 2, latest May 5, 2021 2021: Labeling · 2018: Labeling |
Generic approvals (3)
- ANDA211591Qilu Pharm Hainan · February 13, 2023
- ANDA208913Actavis Labs Fl Inc · April 26, 2023
- ANDA212827Natco · May 31, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 349472, 402091 |
|---|---|
| SPL set ID of the quoted label | 827d60e8-7e07-41b7-c28b-49ef1c4a5a41 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA206995, 3 ANDA |
| Active ingredients (FDA) | GEFITINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Iressa, AstraZeneca Pharmaceuticals LP, effective February 28, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →