FDA sets PDUFA goal date for Alexza's Adasuve.
M2 PHARMA-August 22, 2011-FDA sets PDUFA goal date for Alexza's Adasuve(C)2011 M2 COMMUNICATIONS
22 August 2011 - US Alexza Pharmaceuticals Inc (NASDAQ:ALXA) said today that the US Food and Drug Administration (FDA) has accepted the Adasuve New Drug Application (NDA) as a complete, class two response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of 4 February 2012.
On 4 August, Alexza resubmitted the Adasuve NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.
Alexza's NDA is based on a comprehensive clinical development programme including two positive Phase III clinical trials. In addition to the data from the original NDA and supplemental analyses of some of these data, the Adasuve resubmission contains new data from a successfully completed human factors study, stability data from new production batches manufactured in late 2010, updated manufacturing and controls sections addressing findings from the company's pre-approval Inspection, and updated draft labeling and a comprehensive risk evaluation and mitigation strategy (REMS) proposal.
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|Date:||Aug 22, 2011|
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