Alexza Pharmaceuticals, Inc. announced that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. The company plans to resubmit the AZ-004 NDA in July 2011.

In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010. 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. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients. As reported in October 2010, the FDA stated in the CRL that their primary clinical safety concern was related to data from the three Phase 1 pulmonary safety studies with AZ-004.

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Alexza Pharmaceuticals, Inc.