Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in October 2010. The Company believes this is a Class 2 resubmission with a six-month review cycle. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.
In addition to the data from the original NDA and additional analyses of some of those data, the AZ-004 resubmission contains new data from the successfully completed human factors study, stability data from new production batches manufactured late last year, updated manufacturing and controls sections addressing findings from the Company's Pre-Approval Inspection, and updated draft labeling and a comprehensive REMS proposal.
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