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