Jane S. Ricciuti, RPh, MS


January 23, 2004

In This Article


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:


  • Fragmin (dalteparin sodium) Injection


  • 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


  • 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


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