Jane S. Ricciuti, RPh, MS


January 16, 2003

In This Article


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

Antidiabetic agents

  • Avandia (rosiglitazone maleate) Tablets

  • Starlix (nateglinide) Tablets

Antineoplastic agents

  • Gleevec (imatinib mesylate)

  • Taxotere (docetaxel) Injection

Antipsychotic agents

  • Clozaril (clozapine) Tablets

Antiviral agents

  • 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

Rheumatologic agents

  • Humira (adalimumab)


  • Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B [recombinant] and inactivated poliovirus vaccine combined)


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