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New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 2000 and New Indications for Previously Approved Agents

Date of approval Trade name (form) Generic name(s) Manufacturer Indications or use 24 Jan 00 Primsol (solution) Trimethoprim hydrochloride oral solution Ascent Pediatrics Inc. For a 50-mg (base)/5-ml oral solution 2 Feb 00 Levaquin (injectable, tablet) Levofloxacin R. W. Johnson Pharmaceutical Research Institute, Ortho Pharmaceutical Corp. For treatment of levofloxacin-susceptible, penicillin-resistant S. pneumoniae in patients with community-acquired pneumonia 3 Mar 00 Biaxin XL Filmtab (extended-release tablet) Clarithromycin Abbott Laboratories For acute exacerbations of chronic bronchitis and acute maxillary sinusitis 17 Mar 00 Lamisil (solution) Terbinafine hydrochloride Novartis Pharmaceuticals Corp. For treatment of athlete's foot, tinea cruris, and tinea corporis due to Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum 24 Apr 00 Zyvox (tablets, intravenous, oral suspension) Linezolid Pharmacia & Upjohn For treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonias 26 Apr 00 Relenza (powder for inhalation) Zanamivir Glaxo Wellcome Inc. For treatment of uncomplicated acute illness due to influenza A and B viruses in pediatric patients 7 years and older who have been symptomatic for no more than 2 days 14 Jul 00 Malarone (tablet) Atovaquone; proguanil hydrochloride Glaxo Wellcome Inc. For treatment and prevention of Plasmodium falciparum malaria 25 Jul 00 Abreva (cream) Docosanol Avanir Pharmaceuticals For treatment of cold sores and fever blisters 18 Aug 00 Quixin (solution, drops) Levofloxacin Santen Inc. For treatment of bacterial conjunctivitis 30 Aug 00 Cipro (tablets, injectable) Ciprofloxacin Bayer Corp. For inhalational anthrax (postexposure) 15 Sep 00 Kaletra (capsule, solution) Lopinavir, ritonavir Abbott Laboratories For treatment of HIV-1 infection in adults and pediatric patients 6 months of age and older 8 Sep 00 Levaquin (injectable, tablet) Levofloxacin R. W. Johnson Pharmaceutical Research Institute, Ortho Pharmaceutical Corp. For treatment of complicated skin and skin structure infections; 750-mg dose 20 Oct 00 Biaxin (tablet) Clarithromycin Abbott Laboratories Addition of Haemophilus influenzae to previously approved indication for community-acquired pneumonia for Biaxin Filmtab 31 Oct 00 Videx EC (delayed-release capsules) Didanosine Bristol-Myers Squibb In combination with other antiretroviral agents for treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation 14 Nov 00 Trizivir (tablet) Abacavir sulfate, lamivudine, zidovudine Glaxo Wellcome Inc. For use either alone or in combination with other antiretroviral agents for treatment of HIV-1 infection 17 Nov 00 Tamiflu (capsule) Oseltamivir phosphate Hoffmann-La Roche Inc. For prophylaxis of influenza virus in adults and adolescents 13 years of age and older 27 Nov 00 Benzamycin (gel) Erythromycin, benzoyl peroxide Dermik Laboratories Inc. For treatment of acne vulgaris 14 Dec 00 Tamiflu (oral suspension) Oseltamivir Hoffmann-La Roche Inc. For treatment of uncomplicated acute illness due to influenza virus in patients older than 1 year of age who have been symptomatic for no longer than 2 days