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US FDA's Advisory Committee to meet on Jun 2 to discuss cethromycin NDA of Advanced Life Science

ChicagoThursday, March 5, 2009, 08:00 Hrs  [IST]

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.

 
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