Jane S. Ricciuti, RPh, MS

Disclosures

March 19, 2003

In This Article

Introduction

In February 2003, the United States Army received Food and Drug Administration (FDA) approval for pyridostigmine bromide under new regulations that do not require human efficacy studies. As part of the FDA's initiative for countering bioterrorism, the agency is focusing on the expeditious development and licensing of products to diagnose, treat, or prevent outbreaks from exposure to pathogens that have been identified as bioterrorism agents. Pyridostigmine was granted limited approval for use by US military personnel to increase survival after exposure to the nerve agent soman.

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

Antiasthmatic Agents

  • Pulmicort Respules (budesonide inhalation suspension)

Antidepressants

  • Effexor XR (venlafaxine hydrochloride) Extended Release Capsules

Antineoplastic Agents

  • Eligard (leuprolide acetate) Injection

  • Femara (letrozole) Tablets

  • Gliadel Wafer (polifeprosan 20 with carmustine implant)

Antiretroviral Agents

  • Zerit XR Extended-Release (stavudine) Capsules

Central Nervous System Agents

  • Permax (pergolide mesylate) Tablets

Dermatologic Agents

  • Finacea (azelaic acid) Gel, 15%

Immunosuppressive Agents

  • Sandimmune (cyclosporine)

Neurologic Agents

  • Avonex (interferon beta-1a)

Parasympathomimetic (Cholinergic)/Antibioterrorism Agents

  • Pyridostigmine bromide

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