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news.The FDA has approved Bayer Pharmaceuticals and Schering-Plough's once-daily broad-spectrum antibiotic Avelox in a new indication. The drug is now approved for the treatment of complicated intra-abdominal infections in adults.
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Avelox is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication. The FDA approval for this disorder is the sixth indication for the drug, which was developed by Bayer Pharmaceuticals and is marketed in the US 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 US each year, with many patients contracting the infection secondary to appendicitis.
“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 IV (intravenous) to oral therapy when they leave the hospital,” said Dr Joseph Solomkin, director of research of the division of trauma/critical care at the University of Cincinnati College of Medicine.