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FDA Approves Schering-Plough’s Avelox Antibiotic

The drug treats complicated skin and skin structure infections caused by certain bacteria.Drug maker Schering-Plough (NYSE: SGP) in Kenilworth said the Food and Drug Administration (FDA) has approved its Avelox antibiotic to treat deep-tissue skin infections, the fifth indication for the drug. The antibiotic was previously approved to treat certain types of sinus inflammation, bronchitis, pneumonia and uncomplicated skin infections.

The latest approval covers complicated skin and skin structure infections caused by certain bacteria—Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae. Such infections involve deeper soft tissue such as muscle and fat and the abscesses sometimes need to be removed through surgery.
The company said there are about 2.5 million cases of these infections annually in the U.S. They are often treated by high doses of antibiotics multiple times a day, whereas Avelox is a once-a-day therapy.
Schering-Plough sells Avelox in the U.S. under an agreement with developer Bayer.
At 12:45 p.m. Schering-Plough shares were down $0.42 to $19.20.

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