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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

avin: "The goal of our biodefense program is to attract development funding from the U.S. Government that will ultimately lead to the acquisition of Restanza for the Strategic National Stockpile. The notice that we received from BARDA gives us confidence that we can attract additional development funding in the near term and the clearly defined regulatory pathway for the biodefense indications established with FDA will significantly increase our prospects for further development and acquisition contracts with the Department of Health and Human Services and the Department of Defense."

Background

Advanced Life Sciences submitted the Restanza NDA in September, 2008 based on the results of 53 clinical studies including 2 pivotal phase III studies wherein Restanza demonstrated non-inferiority to Biaxin in mild-to-moderate CABP.

On June 2, 2009, the FDA AIDAC reviewed the Restanza NDA. The AIDAC voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CABP, but voted that Restanza did not demonstrate efficacy in the treatment of CABP in light of the new FDA draft CABP guidance which was published in March of 2009.


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SOURCE Advanced Life Sciences Holdings, Inc.
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