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From the Food and Drug Administration
April 5, 2000

First Drug for Penicillin-Resistant Community-Acquired Pneumonia

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JAMA. 2000;283(13):1679. doi:10.1001/jama.283.13.1679-JFD00002-2-1

The FDA has approved a new indication for levofloxacin (Levaquin; Ortho-McNeil Pharmaceutical Inc, Raritan, NJ), a fluoroquinolone previously approved to treat a wide range of gram-negative and gram-positive microorganisms, including the major pathogens in bacterial community-acquired pneumonia (CAP). The added indication is the first treatment to be approved for adult patients with CAP caused by penicillin-resistant strains of Streptococcus pneumoniae.

The supplemental approval is based on eight clinical studies involving more than 3900 patients with CAP. About 3000 of them were treated with 500 mg of levofloxacin once daily, orally or intravenously, for 7 to 14 days, and the rest received one of several comparator regimens. Across these studies, 18 levofloxacin-treated and four nonquinolone comparator–treated patients were identified with CAP due to penicillin-resistant S pneumoniae.

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