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FDA OK's Schering-Plough's Avelox


Posted on 2005-11-30 12:56:00



Schering-Plough Corp. said Wednesday that it added the treatment of stomach infections to the growing list of uses for its licensed antibiotic Avelox.

The company said the Food and Drug Administration approved Avelox as a standalone treatment for complicated intra-abdominal infections in adults. About 3.5 million cases are reported in the U.S. each year. The infections occur when disease, trauma or surgery allow bacteria to leak from the gastrointestinal tract into nearby tissue. Schering-Plough said the approval makes Avelox the only standalone treatment available to treat these infections.

The new indication is the sixth granted by the FDA. Avelox is also approved to treat bacterial sinusitis, chronic bronchitis, pneumonia, as well as uncomplicated and complicated skin infections.

Since Schering-Plough acquired U.S. rights to market Avelox from Bayer AG in October 2004, the company has reported sales of $203 million of the drug as of Sept. 30.