Jane S. Ricciuti, RPh, MS


November 19, 2002

In This Article


In October 2002, the Food and Drug Administration (FDA) approved a second pegylated interferon, Pegasys (peginterferon alfa-2a), for the treatment of hepatitis C infection. Zetia (ezetimibe) is a new drug approved with a novel mechanism of action to treat hypercholesterolemia.

The FDA approved 2 new antidiabetic combination tablet products -- Avandamet (rosiglitazone maleate and metformin hydrochloride) and Metaglip (glipizide and metformin hydrochloride). Also approved for the treatment of type 2 diabetes are supplemental indications for Glucovance (glyburide and metformin hydrochloride) and Prandin (repaglinide).

Abbokinase (urokinase) returns to the US market after being withdrawn in 1999 due to manufacturing problems with human cell components.

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

Antibiotic Agents

  • Tequin (gatifloxacin)

Antidiabetic Agents

  • Avandamet (rosiglitazone maleate and metformin hydrochloride)

  • Glucovance (glyburide and metformin hydrochloride) tablets

  • Metaglip (glipizide and metformin hydrochloride) tablets

  • Prandin (repaglinide) tablets

Antilipemic Agents

  • Zetia (ezetimibe)

Antimalarial Agents

  • Lariam (mefloquine hydrochloride) tablets

Antiseptic Agents

  • ChloraPrep One-Step Sepp Applicators (2% chlorhexidine gluconate solution)

Antiviral Agents

  • Pegasys (peginterferon alfa-2a) Injection

Cardiovascular Agents

  • Abbokinase (urokinase)

Dermatologic Agents

  • Avage (tazarotene) cream, 0.1%

Opiate Dependence

  • Suboxone (CIII) (buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets) and Subutex (CIII) (buprenorphine hydrochloride sublingual tablets)

Urologic Agents

  • Avodart (dutasteride) capsules


  • Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein])


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