Document Detail

Overview on guidelines and recommendations for generic low-molecular-weight heparins.
MedLine Citation:
PMID:  21262425     Owner:  NLM     Status:  Publisher    
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.
Job Harenberg
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Publication Detail:
Journal Detail:
Title:  Thrombosis research     Volume:  127S3     ISSN:  1879-2472     ISO Abbreviation:  -     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-1-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0326377     Medline TA:  Thromb Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  S100-S104     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Elsevier Ltd. All rights reserved.
Clinical Pharmacology, Faculty of Medicine Mannheim, Mannheim, Germany.
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