Jane S. Ricciuti, RPh, MS

Disclosures

October 23, 2002

In This Article

Introduction

The US Food and Drug Administration (FDA) approved 2 original drug applications in September 2002. The first is Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B. The second is Inspra (eplerenone) for the treatment of hypertension.

Antihypertensives Avapro (irbesartan) and Cozaar (losartan) gained approval for a new indication for use in patients with type 2 diabetes for the treatment of nephropathy.

This month's column reviews FDA new product approvals and labeling changes for these products as well as the following:

Antifungal Agents

  • Cancidas (caspofungin)

Antihypertensive Agents

  • Atacand (candesartan cilexetil)

  • Avapro (irbesartan)

  • Cozaar (losartan)

  • Inspra (eplerone)

Anti-Infective Agents

  • Augmentin XR extended-release tablets

Antilipemic Agents

  • Mevacor (lovastatin)

Antiviral Agents

  • Hepsera (adefovir dipivoxil)

  • Valtrex (valacyclovir)

Dermatologic Agents

  • Aldara

Gastrointestinal Agents

  • Prevacid SoluTab (lansoprazole)

Nonsteroidal Antiestrogens

  • Nolvadex (tamoxifen)

Vaccines

  • Fluzone (preservative-free influenza virus vaccine) intramuscular injection

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