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These highlights do not include all the information needed to use GEFITINIB TABLETS safely and effectively. See full prescribing information for GEFITINIB TABLETS . GEFITINIB tablets, for oral use Initial U.S. Approval: 2015
Medication labelWhy this: Advisory · dailymed-prescription
Gefitinib tablets are 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 [see Clinical Studies (14 ) ]. Limitation of Use: Safety and efficacy of gefitinib tablets 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 [see Clinical Studies (14) ].
- generic_name
- gefitinib
- product_names
- Gefitinib
- ndc
- 0480-4053, 0480-4053-56
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en