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

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily, broad-spectrum antibiotic AVELOX (moxifloxacin HCl) for a new use the treatment of complicated intra-abdominal infections (cIAI) in adults. AVELOX is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication. The FDA approval to treat cIAI is the sixth indication for AVELOX.

AVELOX, available in tablet and intravenous (I.V.) formulations, was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough.

Intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that cause bacteria to leak from the gastrointestinal tract into adjacent tissue there are approximately 3.5 million cases in the United States each year, with many patients contracting the infection secondary to appendicitis. [1]

"The FDA approval of AVELOX to treat complicated intra-abdominal infections is welcome news, providing doctors with an effective treatment option for their patients, and giving patients convenient once-daily dosing and an easy transition from I.V. to oral therapy when they leave the hospital," said Joseph S. Solomkin, M.D., professor in the department of surgery and director of research of the division of trauma/critical care at the University of Cincinnati College of Medicine.

With this FDA approval, AVELOX is indicated for the treatment of adults with cIAI, including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

The FDA approval was based on results from clinical studies in cIAI patients showing that sequential I.V. or oral monotherapy with AVELOX once daily was


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