| Document Date: 2004-01-13 09:43:38
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Company Ames / Alteon Inc. / / Country United States / / Currency pence / USD / / Event FDA Phase / Product Issues / / IndustryTerm treatment of depression / treatment for depression / telephone conversation / treatment of depressionmajor depressive disorder / food / treatment of major depressive disorder / piperazinoazepine / tetracyclic chemical structure / / MedicalCondition major depressive disorder / hepatocellular adenoma / myoclonus / only one seizure / seizures / significant orthostatic hypotension / ischemic stroke / coma / nausea / stomatitis / cerebrovascular disease / carcinoma / hypersomnia / tremor / fatigue / drowsiness / disorder / angina / hypersensitivity / Agranulocytosis / hypotension / sore throat / insomnia / flushing / depressive disorder / chills / Carcinogenesis / neutropenia / occasional orthostatic hypotension / fever / Orthostatic hypotension / vomiting / myocardial infarction / diseases / concomitant systemic illness / infection / dizziness / hepatocellular tumors / depression / thyroid follicular adenoma/cystadenoma / Syndrome / significant heart disease / psychomotor agitation / dehydration / / MedicalTreatment drug therapy / / Organization Alcohol Concomitant administration / PRECAUTIONS / DOSAGE AND ADMINISTRATION / Diazepam Concomitant administration / / Person Edna Givary / Agranulocytosis Patients / Paul David / / Position physician / General / Major / / Product mirtazapine / S-009 Approved / Diazepam / Remeron / S-009 / activities / hepatic function / / Technology CGI / Pharmacokinetics / DNA synthesis / Pharmacodynamics / /
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NDA[removed]S-009 Approved Labeling Enclosure Page 1 ATTACHMENT