To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Committee Recommends Avelox For Respiratory Tract Infections URL: http://www.pslgroup.com/dg/13D2EE.htm Doctor's Guide October 22, 1999
SILVER SPRING, MD. -- October 22, 1999 -- An advisory committee to the U.S. Food and Drug Administration (FDA) today recommended approval of Avelox™ (moxifloxacin HCl), a new quinolone antibiotic developed by Bayer, for the treatment of acute sinusitis, acute bacterial exacerbations of chronic bronchitis (ABECB), community-acquired pneumonia, and uncomplicated skin and skin structure infections.
"We are very pleased that after reviewing the data, the FDA advisory committee has recognized the value of Avelox for treatment of many common community-acquired respiratory tract infections," said Lawrence E Posner, MD, senior vice president, pharmaceutical development, Bayer Corporation, Pharmaceutical Division. "Many of the pathogens responsible for community-acquired respiratory tract infections have developed resistance to the most commonly prescribed antibiotics, creating a real and very immediate need for new agents to fill the void."
Bayer presented data for Avelox based on clinical trials involving nearly 8,000 patients. In these trials, Avelox was evaluated for efficacy in eradicating pathogens such as S pneumoniae, H influenzae, and M catarrhalis, as well as atypical bacteria.
If the FDA accepts the recommendation of its advisory committee, Avelox could be approved for marketing before the end of 1999. Avelox has been approved for marketing in eight countries, including Germany and Switzerland.
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