| Document Date: 2009-03-31 14:51:21
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Company HBV / Novartis Pharmaceuticals Corporation / / Currency pence / / Event FDA Phase / M&A / / Facility Laboratory Abnormalities Frequencies / Laboratory Abnormalitiesa / / IndustryTerm hepatitis B therapy / hepatitis B treatment / food / chemical / healthcare providers / / MedicalCondition ULN Neutropenia / muscular weakness / myalgia / myofascial pain syndrome / HIV / headache / Myopathy / nausea / Thrombocytopenia / muscle weakness / HEPATITIS B / Peripheral Neuropathy / muscle cramp / numbness / fatigue / obesity / diarrhea / End stage renal disease / hepatitis / Nutrition Disorders Lactic acidosis / Pruritus / liver disease / neck pain / back pain / abdominal pain / severe renal dysfunction / insomnia / non-cardiac chest pain / disease / arthralgia / aches / musculoskeletal chest pain / Carcinogenesis / peripheral neuropathy occurrence / Liver Diseases / ESRD / HCV / rhabdomyolysis / Connective Tissue Disorders Rhabdomyolysis Nervous System Disorders / pain / Lactic acidosis / concomitant disease / myositis / chronic hepatitis B. Telbivudine pharmacokinetics / histologically active disease / infection / dizziness / cough / myopathy/myositis / rash / chronic hepatitis B / / MedicalTreatment Liver Transplant / hemodialysis / drug therapy / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position Major / / Product zidovudine / cyclosporine / niacin / polyethylene glycol / erythromycin / tenofovir disoproxil fumarate / talc / Tyzeka / lamivudine / telbivudine / dose / / PublishedMedium Microbiology / / Technology Geriatrics / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION ----------------------DOSAGE FORMS AND STRENGTHS--------------------• Tablet: 600-mg tablets supplied in 30-count bottles[removed]These highlights do not include all the informati