New Drug Approvals Archive - May 2003

Iressa (gefitinib) Tablets

Date of Approval: May 5, 2003
Company: AstraZeneca
Treatment for: Non-Small Cell Lung Cancer

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.

• Iressa AstraZeneca - Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)

Velcade (bortezomib) for Injection

Date of Approval: May 13, 2003
Company: Millennium Pharmaceuticals
Treatment for: Multiple Myeloma

Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma and mantle cell lymphoma.

• FDA Approves Velcade (bortezomib) for Multiple Myeloma

Velcade (bortezomib)

Patient Population Altered: October 10, 2007

• FDA Expands Velcade (Bortezomib) for Injection Label for Patients with Multiple Myeloma

Velcade (bortezomib)

New Indication Approved: June 20, 2008

• FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Velcade (bortezomib)

Labeling Revision Approved: December 30, 2009

• FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Velcade (bortezomib)

New Dosage Regimen: January 23, 2012

• FDA Approves Subcutaneous Administration of Velcade In All Approved Indications

Iressa (gefitinib)

New Indication Approved: July 13, 2015

• FDA Approves Iressa (gefitinib) for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer