New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 2006 and New Indications for Previously Approved Agents

16 Jan 97 Biaxin (tablet) Clarithromycin Abbott Laboratories Pharmaceutical Products Division New: use in combination with ranitidine bismuth citrate for treatment of patients with an active duodenal ulcer associated with Helicobacter pylori infection 30 Jan 97 Zithromax (injectable) Azithromycin Pfizer Inc. Treatment of community-acquired pneumonia and pelvic inflammatory disease in patients who require initial intravenous therapy 7 Feb 97 Femstat One (emulsion) Butoconazole nitrate Syntex Laboratories Inc. Treatment of vulvovaginal infections caused by Candida albicans 11 Feb 97 Vagistat-1 (ointment) Tioconazole Bristol-Myers Products Inc. Provides for over-the-counter marketing of Vagistat-1 vaginal ointment, 6.5%, 1-day vaginal antifungal treatment regimen for treatment of recurrent vaginal yeast infections (candidiasis) 12 Feb 97 Unasyn (injectable) Ampicillin sodium, sulbactam sodium Pfizer Laboratories, division of Pfizer Inc. New: treatment of skin and skin structure infections in pediatric patients aged 3 months to 12 years caused by microorganisms previously included in the indications for use 21 Feb 97 Sporanox (solution) Itraconazole Janssen Research Foundation, division of Johnson and Johnson Treatment of oropharyngeal and esophageal candidiasis