October 2003

Introduction

In September, the US Food and Drug Administration (FDA) approved the first agent in a new class of antibiotics called cyclic lipopeptide antibacterial agents. Cubicin (daptomycin) is indicated for the treatment of complicated skin and skin structure infections caused by gram-positive microorganisms. Daptomycin binds to bacterial membranes and causes a rapid depolarization of membrane potential. The loss of membrane potential leads to inhibition of protein, DNA, and RNA synthesis, which results in bacterial cell death.

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

Antidiabetic Agents

Prandin (repaglinide) Tablets

Antidepressant Agents

Paxil CR (paroxetine HCl) Tablets

Anti-infective Agents

Cipro XR (ciprofloxacin) Extended-Release Tablets Cleocin (clindamycin phosphate) Cream Cubicin (daptomycin) for Injection

Antipsychotic Agents

Abilify (aripiprazole) Tablets

Antiviral Agents

Valcyte (valganciclovir HCI) Tablets

Cardiovascular Agents

Lopressor (metoprolol tartrate) Injection & Tablets Lotrel (amlodipine and benazepril HCl) Capsules

Immune Globulin

Gamunex (Immune Globulin Intravenous [Human], 10% by Chromatography Process)

Oral Contraceptives

Seasonale (levonorgestrel/ethinyl estradiol) Tablets

Medscape Pharmacists. 2003;4(2) © 2003 Medscape

Cite this: October 2003 - Medscape - Oct 22, 2003.