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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

On July 31, 2009 the FDA provided a complete response letter to Advanced Life Sciences indicating that further clinical work would be required for the approval of Restanza in CABP.  Advanced Life Sciences' pivotal phase III program was designed and conducted under prior FDA guidance and before the new draft guidance document was released.

Over the past two years, the FDA has been conducting public workshops and advisory panels to discuss clinical trial design issues in CABP culminating in a draft guidance document published in March of 2009.  Public comments were received in response to the draft guidance and a public AIDAC meeting was held in December of 2009 to further discuss and resolve the CABP clinical design issues.

About Community Acquired Bacterial Pneumonia (CABP)

CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.  Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of '/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
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