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Title of Journal: J Thromb Thrombolysis

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Abbravation: Journal of Thrombosis and Thrombolysis

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Springer US

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DOI

10.1007/s00423-003-0390-6

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ISSN

1573-742X

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US Food and Drug Administration approval of generi

Authors: Marc Cohen Walter P Jeske Jose C Nicolau Gilles Montalescot Jawed Fareed
Publish Date: 2012/01/11
Volume: 33, Issue: 3, Pages: 230-238
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Abstract

Lowmolecularweight heparins LMWHs have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes Each approved LMWH is a pleotropic biological agent with a unique chemical biochemical biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles As a result LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety Previously the US Food and Drug Administration FDA cautioned against using various LMWHs interchangeably however recently the FDA approved generic versions of LMWH that have not been tested in large clinical trials This paper highlights the biochemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical useDr Cohen has received/receives grant/research support from Sanofi Johnson Johnson and BristolMyers Squibb Served as a consultant to Datascope now Maquet Merck and SanofiAventis member of the speaker bureau for Sanofi Merck and BristolMeyers Squibb Boehringer Ingelheim AstraZeneca and Janssen Dr Jeske has received honoraria from Sanofi Dr Nicolau has research grant funding and/or honoraria from AstraZeneca Bayer Daiichi Sankyo Eli Lilly Co Johnson Johnson GlaxoSmithKline Merck and Pfizer Served as a consultant/advisory board member for AstraZeneca Sanofi and Merck Dr Montalescot has received grant and research support from Sanofi Eli Lilly Co and Guerbet received honoraria from SanofiAventis Eli Lilly Co GlaxoSmithKline Merck The Medicine’s Company and Pfizer and served on advisory boards for SanofiAventis Eli Lilly Co GlaxoSmithKline Merck The Medicine’s Company and Schering Plough Dr Fareed has received honoraria from Sanofi

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  2. Comparison of platelet inhibition by prasugrel versus ticagrelor over time in patients with acute myocardial infarction
  3. Does supervised exercise after deep venous thrombosis improve recanalization of occluded vein segments? A randomized study
  4. Anticoagulation in the management of venous thromboembolism in the cancer patient
  5. Association between sleep condition and arterial stiffness in Chinese adult with nonalcoholic fatty liver disease
  6. In vitro shear stress modulates antithrombogenic potentials of human endothelial progenitor cells
  7. Polymorphism in the methylenetetrahydrofolate reductase (C677T) gene and homocysteine levels: a comparison in Brazilian patients with coronary arterial disease, ischemic stroke and peripheral arterial obstructive disease
  8. Role of thrombophilia testing: con
  9. Venous thromboembolism and cancer: a systematic review
  10. Dabigatran-associated subdural hemorrhage: using thromboelastography (TEG ® ) to guide decision-making
  11. Proceedings of the 10th National Conference on Anticoagulant Therapy
  12. Comparative efficacy of in vitro and in vivo metabolized aspirin in the DeBakey ventricular assist device
  13. The relationship between gender and age with monocyte tissue factor expression
  14. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability
  15. A comparison of direct thrombin inhibitors in the treatment of heparin-induced thrombocytopenia: a single institution experience
  16. Measurement of dabigatran and rivaroxaban in primary prevention of venous thromboembolism in 106 patients, who have undergone major orthopedic surgery: an observational study
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  18. Tailoring clopidogrel dose according to multiple electrode aggregometry decreases the rate of ischemic complications after percutaneous coronary intervention
  19. Cardiovascular risk factors and outcome in patients with retinal vein occlusion
  20. Impact of type of thrombolytic agent on in-hospital outcomes in ST-segment elevation myocardial infarction patients in the Middle East
  21. Prognostic significance of multidetector computed tomography in normotensive patients with pulmonary embolism: rationale, methodology and reproducibility for the PROTECT study
  22. Increased platelet activation in patients with slow coronary flow
  23. Biomarkers of deep venous thrombosis
  24. Thromboembolic complications following a first isolated episode of superficial vein thrombosis: a cross-sectional retrospective study
  25. The impact of factor Xa inhibition on axial dependent arterial thrombus formation triggered by a tissue factor rich surface
  26. New oral Xa and IIa inhibitors: updates on clinical trial results
  27. Spontaneous coronary thrombosis following thrombolytic therapy for acute cardiovascular accident and stroke: a case study
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  35. Evaluation of von Willebrand factor and ADAMTS-13 antigen and activity levels in sickle cell disease patients in Kuwait
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