Overview on guidelines and recommendations for generic low-molecular-weight heparins. 2011

Job Harenberg
Clinical Pharmacology, Faculty of Medicine Mannheim, Mannheim, Germany. job.harenberg@medma.uni-heidelberg.de

The first generic low-molecular-weight heparin (LMWH) was approved by the Food and Drug Administration (FDA) end of July 2010 for clinical use in all medical indications where the branded product enoxaparin has reached approval. Many LMWHs have been approved for prophylaxis and the treatment of venous and arterial thromboembolism based on the results of large clinical trials. Generic LMWHs are now marketed in various countries. The European Medicines Agency (EMA) has set up guidelines for the production of generic LMWHs. The International Society of Thrombosis, the North American Thrombosis Forum and other scientific organisations raised concerns regarding the safety of generic LMWHs due to the possibility of a reduced quality of the anticoagulants to ensure a lower price compared to the branded LMWHs. They have published statements for the production of generic LMWHs to ensure the quality of the products and the safety for patients. The present review describes the differences between the actual guidelines and recommendations for the production of generic version of LMWHs.

UI MeSH Term Description Entries
D006495 Heparin, Low-Molecular-Weight Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism. LMWH,Low-Molecular-Weight Heparin,Low Molecular Weight Heparin,Heparin, Low Molecular Weight
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000925 Anticoagulants Agents that prevent BLOOD CLOTTING. Anticoagulant Agent,Anticoagulant Drug,Anticoagulant,Anticoagulant Agents,Anticoagulant Drugs,Anticoagulation Agents,Indirect Thrombin Inhibitors,Agent, Anticoagulant,Agents, Anticoagulant,Agents, Anticoagulation,Drug, Anticoagulant,Drugs, Anticoagulant,Inhibitors, Indirect Thrombin,Thrombin Inhibitors, Indirect
D013923 Thromboembolism Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream. Thromboembolisms
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D016568 Drugs, Generic Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies. Drugs, Nonproprietary,Generic Drug,Generic Drugs,Drug, Generic,Nonproprietary Drugs

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