Advanced Life Sciences Holdings, Inc, has received notice from the US Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on June 2, 2009, and will discuss the New Drug Application (NDA) for cethromycin, a new once-a-day oral antibiotic for the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).
In November, 2008, the FDA filed the company's NDA for cethromycin and established a target Prescription Drug User Fee Act (PDUFA) action date for the cethromycin NDA of July 31, 2009.
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.