Jane S. Ricciuti, RPh, MS


December 15, 2004

In This Article


The US Food and Drug Administration (FDA) approved Tysabri (natalizumab), a monoclonal antibody, for the treatment of patients with multiple sclerosis. Natalizumab is a recombinant humanized IgG4-kappa monoclonal antibody and has been approved for use in reducing the frequency of symptom flare-ups or exacerbations of the disease.

A new agent in the field of oncology has been approved, Tarceva (erlotinib), for the treatment of patients with non-small-cell lung cancer. Eloxatin (oxaliplatin) received a supplemental approval for use in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV) for the adjuvant treatment of stage 3 colon cancer patients who have undergone complete resection of the primary tumor.

This month's column reviews FDA new product approvals and labeling changes for:

Antilipemic Agents

  • Omacor (omega-3 acid ethyl esters) Capsules

  • Tricor (fenofibrate) Tablets

Antineoplastic Agents

  • Eloxatin (oxaliplatin) Injection

  • Tarceva (erlotinib) Tablets

Central Nervous System Agents

  • Zomig(zolmitriptan) Tablets

Miscellaneous Agents

  • Mifeprex (mifepristone) Tablets

  • Tysabri (natalizumab) Injection


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