Jane S. Ricciuti, RPh, MS


March 02, 2005

In This Article


On February 15, 2005, the President of the United States announced the nomination of Lester M. Crawford, DVM, PhD, to be Commissioner of the Food and Drug Administration (FDA), Department of Health and Human Services. Dr. Crawford has been in the role of Acting Commissioner of the FDA during several vacancies in the commissioner post. The FDA has been under increased scrutiny mainly due to numerous drug safety issues and a decrease in the approval of novel therapies. Dr. Crawford immediately announced on February 15 the creation of a new independent Drug Safety Oversight Board to oversee the management of drug safety issues at the FDA.

As seen in 2004, novel drug approvals have been consistently low in 2005. One new product approved is Vaccinia Immune Globulin Intravenous (Human) (VIGIV), which contains vaccinia-specific immunoglobulin G (IgG) representative of immunized donors.

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

Antineoplastic Agents

  • Doxil (doxorubicin HCl liposome) Injection

Immune Globulin

  • Vaccinia Immune Globulin Intravenous (Human) (VIGIV)

Opiate Agonists

  • Duragesic (fentanyl transdermal system)

Vitamin B Complex

  • Nascobal (cyanocobalamin) Nasal Spray