CHICAGO, Dec. 3 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's New Drug Application (NDA) for cethromycin, a novel once-a-day oral antibiotic, for the treatment of mild-to-moderate community acquired pneumonia (CAP). 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.
"We will work closely with the FDA to facilitate its review of our NDA for cethromycin," said Michael T. Flavin, Ph.D., the Company's chairman and chief executive officer. "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."
The cethromycin 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 CAP in which cethromycin was dosed orally at 300 milligrams once daily for seven days compared to the standard of care therapy, Biaxin(R), which was dosed orally at 250 milligrams twice daily for seven days. The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile.
More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP and
other respiratory tract infections are caused by pathogens such as
|SOURCE Advanced Life Sciences Holdings, Inc.|
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