Presently, the US Food and Drug Administration (FDA) and regulatory agencies in other countries have approved one DTI (dabigatran etexilate, Pradaxa~R) and two DFXal (rivaroxaban, Xarelto~R; apixaban, Eliquis~R) for one or more indications, and clinical trials that were recently completed or ...
After having approved Pradaxa in 2010, the FDA reexamined the drug following receipt of a large number of reports of bleeding among Pradaxa users. As a result, the FDA compared the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa with those of new us...
human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in...
Warfarin has FDA approval for the prophylaxis and treatment of venous thrombosis and its complications, such as a pulmonary embolus. It is also indicated to prevent thromboembolic complications associated with conditions such as atrial fibrillation, cardiac valve replacement, and inherited genetic factors ...
The FDA approved warfarin in June 1954. What brand names are available for warfarin? Coumadin, Jantoven Is warfarin available as a generic drug? GENERIC AVAILABLE: Yes Do I need a prescription for warfarin? Yes What are the uses for warfarin? Warfarin is used in treating patients with deep ...
Gaining access to one of the new agents before it is approved for marketing by the FDA usually requires special circumstances and a special application by your physician. In many cases, however, the allergy is to the dye used in the tablets rather than to the warfarin itself. If your ...
FDA-approved clinical uses for warfarin: Prophylaxis and treatment of venous thrombosis and arising pulmonary embolisms[1][2][1] Prophylaxis and treatment of thromboembolic complications from atrial fibrillation or cardiac valve replacement[1] Reduction in the risk of death, recurrent myocardial infarction...
Hematologists, other healthcare providers, consumers[Posted 08/16/2007] FDA approved updated labeling to include pharmacogenomics information to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for the widely used blood-thinning drug, Coumadin. Th...
申请号 040415 申请类型 ANDA 商品名 Warfarin Sodium 活性成分 Warfarin Sodium 申请机构 Aurobindo Pharma Usa 批准日期 2004-09-27 申请备注 数据来源 产品信息 产品号 商品名 活性成分 剂型 给药途径 规格 参比制剂 标准制剂 市场状态 治疗等效性代码 001 Warfarin Sodium Warfarin Sodium Tablet Oral 1mg No...
Drug class: coumarins and indandiones Breastfeeding En español Patient resources Warfarin drug information Professional resources Warfarin prescribing information Other brands Coumadin, Jantoven Related treatment guides Antiphospholipid Syndrome Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery Chr...