New Drug Approvals Archive - May 2003
Iressa (gefitinib) Tablets
Date of Approval: May 5, 2003
Iressa (gefitinib) is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) gene mutations as detected by an FDA-approved test.
Velcade (bortezomib) for Injection
Date of Approval: May 13, 2003
Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma and mantle cell lymphoma.
Patient Population Altered: October 10, 2007
New Indication Approved: June 20, 2008
Labeling Revision Approved: December 30, 2009
New Dosage Regimen: January 23, 2012
New Indication Approved: July 13, 2015