Application Nr Approved Date Route Status External Links
NDA206995 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 [See Clinical Studies (14) ] . 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 [See Clinical Studies (14) ] . Iressa Is 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 Iressa Have Not Been Established In Patients Whose Tumors Have Egfr Mutations Other Than Exon 19 Deletions Or Exon 21 (L858r) Substitution Mutations. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Gefitinib GEFITINIB ZINC19632614

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