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Alexza Pharma Says FDA Accepts AZ-004 NDA For Filing; Indicates Goal Date Of Oct. 11 - Quick Facts

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
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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.

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