| Document Date: 2009-03-31 14:50:54
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Company Either Treatment Group / Alteon Inc. / AstraZeneca Pharmaceuticals LP / / Event FDA Phase / Product Issues / / IndustryTerm food / / MedicalCondition interstitial pneumonitis / hypospadias / Headache / liver dysfunction / Urinary Retention / Herpes Zoster / Arthritis / Bronchitis / Urinary Tract Infection / Urinary Incontinence / Hypersensitivity CASODEX / nausea / Rhinitis / Alopecia / gonadotropin-independent precocious puberty / Breast Pain / pulmonary fibrosis / Syncope / Gastrointestinal Disorder / hepatic dysfunction / Gout / fatigue / Angina Pectoris / severe liver injury / Myocardial Infarct / Disorder / Hypersensitivity / diarrhea / Hepatitis / prostate cancer / constipation / Heart Arrest / Neck Pain / Pruritus / Back Pain / Flu Syndrome / Sepsis / Gynecomastia / Asthma / abdominal pain / Insomnia / Epistaxis / Congestive Heart Failure / Pneumonia / advanced prostate cancer / Respiratory System Dyspnea / Hypertension / disease / Neoplasm / dyspnea / Hydronephrosis / pre existing diabetes / Chills / Dysphagia / hematuria / Carcinogenesis / Hyperglycemia / diabetes / Fever / Hernia / Melena / pain / vomiting / progressive precocious puberty / Coronary Artery Disorder / hepatic failure / urticaria / pre-existing diabetes / Skin Carcinoma / Stage D2 metastatic carcinoma / infection / Dizziness / Depression / Impotence / Periodontal Abscess / Rash / Pharyngitis / Paresthesia / anemia / Cataract / interstitial lung disease / familial male-limited precocious puberty / angioneurotic edema / central precocious puberty / Dehydration / / Organization FDA / / Person Chest Pain / / / Position General / / Product flutamide / bicalutamide / CASODEX / anastrozole / estradiol / testosterone / ARIMIDEX / patients / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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v HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CASODEX® safely and effectively. See full prescribing information for CASODEX. CASODEX® (bicalutamide) Tablet fo