Advanced Life Sciences (ADLS) to Hold Meeting With FDA to Discuss the New Drug Application for Cethromycin
Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS) has received notice from the U.S. 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. Further details pertaining to the AIDAC meeting will be provided by Advanced Life Sciences upon receipt of additional information from FDA.
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. [SM]
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. Further details pertaining to the AIDAC meeting will be provided by Advanced Life Sciences upon receipt of additional information from FDA.
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. [SM]
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