Announced today that it offers resubmitted its AZ-004 New Drug Application to the U.

In addition to the data from the original NDA and extra analyses of some of these data, the AZ-004 resubmission contains fresh data from the completed human being factors study successfully, stability data from fresh production batches manufactured late last year, updated manufacturing and settings sections addressing findings from the Company’s Pre-Approval Inspection, and updated draft labeling and a comprehensive REMS proposal.. Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients Alexza Pharmaceuticals, Inc. announced today that it offers resubmitted its AZ-004 New Drug Application to the U.S. Food and Drug Administration in response to a Full Response Letter received in October 2010.The patient could be treated conservatively with systemic methotrexate in a program similar to that for tubal ectopic pregnancy. Medical type of management is appropriate for unruptured pregnancies with significantly less than eight weeks duration with considerable thickness between the myometrium and urinary bladder. Consent for surgical intervention however, must be taken. Sac aspiration under ultrasound guidance can be carried out, along with regional injection of embryocidal agent such as methotrexate, potassium chloride, hyperosmolar glucose etc.