January 2004

Introduction

Pediatric clinical information has been approved to provide updated labeling information to 2 products. Malarone (atovaquone and proguanil hydrochloride) has received US Food and Drug Administration (FDA) approval for use in pediatric patients weighing 5-11 kg for the treatment of Plasmodium falciparum malaria. Xenical (orlistat) has been approved by the FDA for use in the management of obesity in adolescent patients aged 12-16 years.

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

Anticoagulants

Fragmin (dalteparin sodium) Injection

Anticonvulsants

Topamax (topiramate) Tablets/Sprinkle Capsules

Antifungal Agents

Ertaczo (sertaconazole nitrate) Cream, 2% Vfend (voriconazole) Oral Suspension

Anti-infective Agents

Levaquin (levofloxacin) Tablets & Injection Malarone (atovaquone and proguanil hydrochloride) Tablets

Antipsychotics

Clozaril (clozapine) Tablets Risperdal (risperidone) Tablets, Oral Solution & Disintegrating Tablets

Central Nervous System Agents

Permax (pergolide mesylate)

Gastrointestinal Agents

Xenical (orlistat) Capsules Zorbtive (somatropin [rDNA origin]) for Injection

Medscape Pharmacists. 2004;5(1) © 2004 Medscape

Cite this: January 2004 - Medscape - Jan 26, 2004.