New antimicrobial agents approved by the US Food and Drug Administration in 2003 and new indications for previously approved agents.

7 Jan 03 Cancidas (injection) Caspofungin acetate Merck Research Laboratories For treatment of candidemia and intraabdominal-abscess, peritonitis, and pleuralspace Candida infection 28 Feb 03 Avelox (tablets, injection) Moxifloxacin hydrochloride Bayer Corporation Modification of community-acquired pneumonia indication to include penicillin-resistant (MIC 2 g/ml) strains of Streptococcus pneumoniae 13 Mar 03 Fuzeon (injection) Enfuvirtide Hoffmann-La Roche In combination with other antiretrovirals, for treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatmentexperienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy 28 Mar 03 Zymar (ophthalmic solution) Gatifloxacin Allergan For treatment of bacterial conjunctivitis caused by designated susceptible organisms 1 Apr 03 Valtrex (caplets) Valacyclovir hydrochloride GlaxoSmithKline For suppression of recurrent genital herpes in HIV-infected individuals 4 Apr 03 Factive (tablets) Gemifloxacin mesylate LG Life Sciences For treatment of infections caused by susceptible strains of designated microorganisms in acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia 15 Apr 03 Vigamox (ophthalmic solution) Moxifloxacin Alcon For treatment of bacterial conjunctivitis caused by susceptible strains (of listed organisms) 23 May 03 Levaquin (tablets and injection) Levofloxacin Ortho-McNeil For treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis 20 Jun 03 Reyataz (capsules) Atazanavir Bristol-Myers Squibb For treatment of HIV-1 infection in adults in combination with other antiretrovirals 2 Jul 03 Emtriva (capsules) Emtricitabine Gilead Sciences For treatment of HIV-1 infection in adults in combination with other antiretrovirals 18 Jul 03 Ciprodex (sterile otic suspension) Ciprofloxacin and dexamethasone Alcon For treatment of acute otitis media in pediatric patients ( 6 mo old) with tympanostomy tubes due to Staphylococcus aureus, S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, or Pseudomonas aeruginosa and acute otitis externa in pediatric, ( 6 mo old), adult, and elderly patients due to S. aureus or P. aeruginosa 22 Jul 03 Zyvox (tablets, intravenous, oral suspension) Linezolid Pharmacia & Upjohn For treatment of diabetic foot infections