Alexza Pharmaceuticals Inc. (ALXA) said the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act or PDUFA goal date of October 11, 2010.
The company filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients.
For comments and feedback: editorial@rttnews.com