New Drug Approvals Archive - May 2003
Iressa (gefitinib) Tablets
Date of Approval: May 5, 2003
Iressa (gefitinib) is an anilinoquinazoline indicated as a monotherapy for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer after failure of both platinum-based and docetaxel chemotherapies.
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