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Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

for AZ-004.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  The Company completed an end-of-review meeting with the FDA in late December 2010.  

The Company believes it has a clear understanding of the issues outlined in the CRL, is developing and executing a plan to address these issues and currently projects a resubmission of the AZ-004 NDA in July 2011.  

For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

This press release includes forward-looking statements regarding the development and safety of the Company's product candidates and technologies.  Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement.  The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements.  These forward-looking statements are based upon Alexza's current expectations.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the potential of the Company's planned NDA resubmission to adequately address the issues in the CRL, the eventual prospects that AZ-004 will be approved for marketing and the timing of the Company's resubmission of the AZ-004 NDA to the FDA.  Alexza's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncerta
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SOURCE Alexza Pharmaceuticals, Inc.
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