The US Food and Drug Administration (FDA) approved Humira (adalimumab), a novel recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira is indicated for the treatment of patients with rheumatoid arthritis.
In December 2002, the FDA also approved 2 antineoplastic agents for first-line therapy. The first is Gleevec (imatinib mesylate) for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia. The second agent is Taxotere (docetaxel) in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer (NSCLC).
Labeling for Premarin (conjugated estrogens) and Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) was also revised to include information on the recent results from the Women's Health Initiative and the increased risk of cardiovascular events and cancer.
This month's column reviews FDA new product approvals and labeling changes for:
Lexapro (escitalopram oxalate) Oral Solution
Avandia (rosiglitazone maleate) Tablets
Starlix (nateglinide) Tablets
Gleevec (imatinib mesylate)
Taxotere (docetaxel) Injection
Clozaril (clozapine) Tablets
Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Combination Therapy
Viread (tenofovir disoproxil fumarate) Tablets
Premarin (conjugated estrogens) Tablets
Prempro and Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets
Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B [recombinant] and inactivated poliovirus vaccine combined)
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: January 2003 - Medscape - Jan 16, 2003.