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Advanced Life Sciences Receives FDA Guidance on Approval Pathway for Restanza in Community Acquired Bacterial Pneumonia and Biodefense Indications
Date:3/11/2010

CHICAGO, March 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

Advanced Life Sciences met with officials from the FDA's Anti-Infectives Division earlier this week to gain clarity on the registration pathway for Restanza. This meeting followed the December 9, 2009 FDA Anti-Infective Drugs Advisory Committee (AIDAC) meeting which discussed clinical trial design issues for CABP relative to the earlier, March 2009, FDA CABP guidance document.  In the meeting, the FDA guided that, to assess the approvability for Restanza to treat CA
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SOURCE Advanced Life Sciences Holdings, Inc.
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