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FDA approves AVELOX (moxifloxacin HCl) for treatment of complicated intra-abdominal infections

as effective as the widely used I.V. therapy piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily. AVELOX was effective at eradicating key pathogens, including E. coli and the anaerobe B. fragilis, which are the most commonly encountered bacteria in cIAI.

"This FDA approval signals yet another important milestone for AVELOX, following the approval of AVELOX for treatment of complicated skin and skin structure infections in June," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "By adding two new indications this year, AVELOX has successfully expanded its utility as a broad-spectrum antibiotic. This will help toward AVELOX becoming a fluoroquinolone of choice for its approved indications."

Patients taking AVELOX for cIAI treatment benefit from the convenience of once-daily therapy and not requiring dosage adjustments when switching from I.V. to oral therapy. Dosage adjustments also are not required for AVELOX patients suffering from renal impairment.

In October 2004, Schering-Plough acquired exclusive U.S. rights to market, sell and distribute AVELOX from Bayer Pharmaceuticals Corporation. As holder of the New Drug Application (NDA) and patents for AVELOX, Bayer completed the research and FDA submission related to this new indication.

The FDA approval to treat cIAI is the sixth indication for AVELOX, which is already approved in the United States to treat acute bacterial sinusitis (ABS); acute bacterial exacerbation of chronic bronchitis (ABECB); community acquired pneumonia (CAP) including CAP caused by multi-drug resistant Streptococcus pneumoniae (MRSP) and penicillin-resistant Streptococcus pneumoniae (PRSP); uncomplicated skin and skin structure infections (uSSSI); and complicated skin and skin structure infections (cSSSI).


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30-Nov-2005


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