Alexza Pharma (ALXA) Says FDA Has Accepted ADASUVE NDA; Sets PDUFA Date

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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) reports that the U.S. Food & Drug Administration (FDA) has accepted the Company's resubmitted ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012. On June 22, 2012, Alexza announced that it had resubmitted the ADASUVE NDA, which seeks marketing approval for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

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