Bayer Pharmaceuticals Corporation

FDA approves Avelox (moxifloxacin HCI) for community-acquired pneumonia

Published in Food and Drug Law Weekly, June 25th, 2004

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Avelox (moxifloxacin HCI) Tablets and I.V. for the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant Streptococcus pneumoniae (MDRSP).

Avelox is the first antibiotic available in both tablet and I.V. forms approved to treat CAP caused by these strains, which are resistant to the antibiotics most commonly used to treat pneumonia.

Two to three million cases of CAP are reported annually in the United States, resulting in 10 million physician visits, 500,000 hospitalizations and 45,000 deaths each year. Currently, CAP is...

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Source: Food and Drug Law Weekly (2004-06-25)

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