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 |