Gefitinib
Gefitinib is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including Gefitinib, IRESSA. Available dosage forms: powder, tablet, film coated, tablet, coated.
Drug Details
- Generic Name
- Gefitinib
- Brand Names
- Gefitinib, IRESSA
- Application Number
- ANDA208913
- Sponsor
- SciAnda (Changshu) Pharmaceuticals, Ltd.
- NDC Codes
- 10
- Dosage Forms
- POWDER, TABLET, FILM COATED, TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- GEFITINIB
Indications and Usage
1 INDICATIONS AND USAGE 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) ]. Gefitinib tablets are a tyrosine kinase inhibitor 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. (1) Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1)