gefitinib tablets
for oral use Initial U.S. Approval: 2015
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.
Facts about gefitinib tablets
Approval Date: 2015
Proprietary Name: On Request
Active Ingredient(s): gefitinib tablets
Dosage Forms And Strengths: Tablets: 250 mg
Company: AstraZeneca
Current indications: non-small cell lung cancer (NSCLC)
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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