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news.Advanced Life Sciences Holdings, a biopharmaceutical company, has announced that the FDA has accepted and filed the company's new drug application for cethromycin, a novel once-a-day oral antibiotic, for the treatment of mild-to-moderate community acquired pneumonia.
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The cethromycin new drug application (NDA) is based on a full clinical development and manufacturing program for cethromycin. The program included two global Phase III pivotal studies for the treatment of mild-to-moderate community acquired pneumonia (CAP) in which cethromycin was dosed orally at 300mg once daily for seven days compared to the standard of care therapy, Biaxin, which was dosed orally at 250mg twice daily for seven days.
The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile. The FDA has established a goal of a standard 10-month review such that the anticipated target action date of the cethromycin NDA would be July 31, 2009.
Michael Flavin, chairman and CEO of Advanced Life Sciences, said: “We will work closely with the FDA to facilitate its review of our NDA for cethromycin. We are excited about the possibility of bringing cethromycin forward to the market as an attractive new oral antibiotic option for physicians to treat mild-to-moderate CAP.”