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ADVANCED LIFE SCIENCES GETS LETTER FROM FDA FOR RESTANZA.

Article Excerpt
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Restanza(TM) (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). In its letter, the FDA indicated that they cannot approve the application for Restanza in its current form and that, to gain approval, additional clinical data is required to demonstrate efficacy. Advanced Life Sciences submitted the NDA in September, 2008 based on the results of 53 clinical studies including 2 pivotal Phase 3 studies in CAP and a safety database of over 5,000 patients.

Advanced Life Sciences intends to comply with the Agency's recommendations and continue to pursue approval of Restanza in CAP. The company believes that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the...

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