Product individuality of commercially available low-molecular-weight heparins and their generic versions: Therapeutic implications

Clinical and Applied Thrombosis/Hemostasis

Volumn 12, Issue 3, 2006, Pages 267-276

  Maddineni, Jyothi ^a   Walenga, Jeanine M ^a   Jeske, Walter P ^a   Hoppensteadt, Debra A ^a   Fareed, Jawed ^a   Wahi, Rakesh ^b   Bick, Rodger L ^c  

^a LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^b Grant Memorial Hospital   (United States)

^c NONE

Author keywords

Generic drugs; Low molecular weight heparins (LMWHS); Pharmacokinetics pharmacodynamics (PK PD); Unfractionated heparin (UFH)

Indexed keywords

ENOXAPARIN; GENERIC DRUG; HEPARIN LYASE; LOW MOLECULAR WEIGHT HEPARIN;

ANTICOAGULATION; ARTICLE; DIGESTION; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; MOLECULAR WEIGHT; PARTIAL THROMBOPLASTIN TIME; PRIORITY JOURNAL; THROMBIN TIME;

BLOOD COAGULATION TESTS; DRUGS, GENERIC; HEPARIN LYASE; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; KINETICS; MOLECULAR WEIGHT; THERAPEUTIC EQUIVALENCY;

EID: 33748754104     PISSN: 10760296     EISSN: None     Source Type: Journal    
DOI: 10.1177/1076029606291434     Document Type: Article

References (17)

1. Merli G, Vanscoy G, Rihn T, et al. Applying scientific critereia to therapeutic interchange: A balanced analysis of low-molecular-weight heparins. J Thromb Thrombolysis 2001;11(3):247.
2. Nightingale SL. Appropriate use of low-molecular-weight heparins. JAMA 1993;270(14):1672.
3. Armstrong EP. Evaluating low-molecular-weight heparins within a health system: Issues and strategies. Formulary 1999;34:144.
4. Boneu B, Caranobe C, Sie P. Pharmacokinetics of heparin and low-molecular-weight heparins. In: Antithrombin Therapy (J Hirsh, ed.) 1990; Balliere's Clinical Haematology, 1990;531.
5. Fragmin (dalteparin sodium) injection (package insert). Kalmazoo, MI: Pharmacia and Upjohn; March 2004.
6. Linhardt RJ, Gunay NS. Production and chemical processing of low-molecular-weight heparins. Semin Thromb Hemost 1999;25(3):5.
7. Innohep (tinzaparin sodium) injection (package insert). Wilmington, DE: DuPont Pharma; July 2004.
8. Fareed J, Hoppensteadt D, Schultz C, et al. Biochemical and pharmacological heterogeneity in low-molecular-weight heparins. Impact on the therapeutic profile. Curr Pharma Design 2004;10:983.
9. Mammen EF, Arcelus J, Messmore H, et al. Clinical differentiation of low-molecular-weight heparins. Semin Thromb Hemost 1999;25(3):135.
10. Food and Drug Administration Center for Drug Evaluation and Research page. FDA website. Available at: http://www.fda.gov/cder/ogd/#Introduction. Accessed May 5, 2004.
11. Fareed J, Leong W, Hoppensteadt D, et al. Development of Generic Low-Molecular-Weight Heparin: A Perspective. Hematol Oncol Clin North Am 2005;19:53.
12. Fareed J, Iqbal O, Nader H, et al. Generic low-molecular-weight heparins: A significant dilemma. Clin Appl Thrombosis/Hemostasis 2005;11(4):T1.
13. Docket No. 2003P-0064/GPI. Request to USFDA for the approval of generic version of lovenox.
14. Ahsan A, Jeske WP, Hoppensteadt DA, et al. Molecular profiling and weight determination of heparins and depolymerized heparins. J Pharma Sci 84:724.
15. Lovenox (enoxaparin sodium) injection (package insert). Bridgewater, NJ: Aventis Pharmaceuticals; July 2004.
16. Citizen Petition by Aventis, February 19, 2003 (03P-0064/CPI).
17. Leong W, Hoppensteadt HD. Generic forms of low-molecular-weight heparins: Some practical considerations. Clin Appl Thromb Hemost 2003;9(4):293.