| Document Date: 2012-12-21 15:44:52
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City Baltimore / Reference / / Company Lupin Pharma / ANTARA / Ames / / Country United States / / Currency pence / / Event Product Issues / FDA Phase / / IndustryTerm food / active chemical moiety fenofibric acid / chemical name / aqueous media / / MedicalCondition nonfatal stroke / cholelithiasis / Myopathy / Venothromboembolic Disease / cirrhosis / human atherosclerosis / testicular interstitial cell tumors / non-fatal myocardial infarction / pre-existing gallbladder disease / pancreatic carcinomas / coronary heart disease / hepatitis / gallstones / pancreatic acinar adenomas / Abdominal Pain / Severe renal dysfunction / pulmonary embolus / benign testicular interstitial cell tumors / cancer / chronic dosing / arthralgia / hypothyroidism / primary hyperlipidemia / pancreatic adenomas / hepatocellular carcinoma / Carcinogenesis / total cardiovascular disease / dyslipidemia / Active liver disease / diabetes / muscle pain / familial hypertriglyceridemia / fever / Respiratory Respiratory Disorder / liver carcinomas / deep vein thrombosis / Pancreatitis / coronary artery disease / increased ALT / renal failure / myopathy/myositis / rash / acute renal failure / Hypercholesterolemia / cholecystitis / basal cell carcinoma / Gallbladder disease / liver adenomas / Headache / primary hypercholesterolemia / muscle spasms / Nausea / Thrombocytopenia / rhinitis / Known hypersensitivity / Stevens-Johnson syndrome / post myocardial infarction / hypersensitivity / Constipation / primary biliary cirrhosis / Back Pain / agranulocytosis / cancers / mixed dyslipidemia / thrombophlebitis / hypertension / atherosclerosis / Reactions Acute hypersensitivity / hypertriglyceridemia / cardiovascular disease / hyperlipidemia / rhabdomyolysis / Pancreatitis Pancreatitis / Severe Hypertriglyceridemia / renal insufficiency / diabetes mellitus / Urticaria / chronic active hepatitis / chronic active and cholestatic hepatitis / nonfatal pulmonary embolism / anemia / / MedicalTreatment surgery / statin therapy / adjunctive therapy / dialysis / hemodialysis / Estrogen therapy / drug therapy / / Organization Antara administration / World Health Organization / DOSAGE AND ADMINISTRATION / FDA / Administration on Systemic Exposure / / Person Floor Baltimore / Indigo / / / Position physician / General / / Product ANTARA / cyclosporine / Glimepiride / Rosiglitazone / gemfibrozil / talc / TRICOR / fenofibrate / clofibrate / Renal Function Treatment / fenofibric / Renal Function / / ProvinceOrState Prince Edward Island / Maryland / / PublishedMedium Baseline / / Technology Geriatrics / dialysis / alpha / Pharmacokinetics / artificial intelligence / DNA synthesis / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ANTARA® safely and effectively. See full prescribing information for ANTARA. ANTARA (fenofibrate) Capsules, for ora