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New Drug Approvals Archive - May 2003

May 2003

May 5

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.

May 13

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.

October 15

Velcade (bortezomib)

Patient Population Altered: October 10, 2007

June 23

Velcade (bortezomib)

New Indication Approved: June 20, 2008

January 5

Velcade (bortezomib)

Labeling Revision Approved: December 30, 2009

January 24

Velcade (bortezomib)

New Dosage Regimen: January 23, 2012

July 13

Iressa (gefitinib)

New Indication Approved: July 13, 2015

New Drug Approvals Archive