The United States food and drugs administration approves a generic enoxaparin

Clinical and Applied Thrombosis/Hemostasis

Volumn 17, Issue 1, 2011, Pages 5-8

  Ofosu, Frederick A ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

deep venous thrombosis; heparins; low molecular weight heparins; thrombosis prophylaxis

Indexed keywords

ARDEPARIN; DALTEPARIN; ENOXAPARIN; GENERIC DRUG; TINZAPARIN;

ASIA; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; REVIEW; SOUTH AMERICA; UNITED STATES;

ANTICOAGULANTS; DRUG APPROVAL; DRUGS, GENERIC; ENOXAPARIN; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78651398366     PISSN: 10760296     EISSN: None     Source Type: Journal    
DOI: 10.1177/1076029610389028     Document Type: Review

References (15)

1. FDA News Release, July 23, 2010. fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm220092.hm. Accessed July 23, 2010.
2. FDA response to Citizen Petition Docket No. FDA-2003-P-0273.
3. Drugs. Establishing Active Ingredient Sameness for Generic Enoxaparin Sodium, a Low Molecular Weight Heparin. fda.gov/Drugs/DrugsSafety/Post- marketDrugSafetyInformationforPatients-andProviders/ucm220023. Accessed July 28, 2010.
4. Drugs. Generic Enoxaparin Questions and Answers. fda.gov/Drugs/ DrugSafety/PostmarketDugSfetyIformationforPtientsandProviders. Accessed July 26, 2010.
5. Drugs. Abbreviated New Drug applications (ANDA): Generics. fda.gov/Drug/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved. Accessed July 26, 2010.
6. Kalodiki E., Leon w ; SASAT, and Task Force on Generic LMWHs. SASAT (South Asian Society on Atherosclerosis and Thrombosis) proposal for regulatory guidelines for generic low molecular weight heparins (LMWHs). Clin Appl Thromb Hemost. 2009 ; 15 (1). 8-11.
7. North American Thrombosis Forum Official Policy Statement regarding the protection of patient safety and patient rights on the matter of follow-on biologics. natfonline.org/NATFbiologiesstatement.php. Accessed July 26, 2010.
8. North American Thrombosis Forum Thoughts on Approval Guidelines for Generic Heparins and Low Molecular Weight Heparins. Written Communications to the FDA. http://www.natfonline.org/ FINAL%20natf%20Written%20communication%20to%20FDA.pdf. Accessed on June 15, 2010.
9. Kalodiki E., Fareed J., Tapson WF, et al. A consensus conference on complex biologics and low molecular weight heparin. Int Angiol. 2010 ; 29: 193-196.
10. EMEA Guidelines on Clinical and Non-Clinical Development of Medicinal Products Containing Low-Molecular-Weight Heparins. London: European Medical Agency ; 2009. EMEA/CHMP/BMWP/11826407enfin.pdf. Accessed July 29, 2010.
11. Harenberg J., Kakkar A., Bergqvist D., et al, on behalf of the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Recommendations on biosimilar low-molecular-weight heparins. J Thromb Haemost. 2009 ; 7 (7). 1222-1225.
12. Emea. Guidelines on Similar Biologic Medical Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. London: European Medicines Agency ; 2006 (EMEA/CHMP/BMWP/42832/2005). http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf. Accessed July 26, 2010.
13. Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2007. Washington, DC: PHRMA, 2007. http//.phrma.org/files/ attachments/2008%20Profile.pdf. Accessed August 18, 2010.
14. WHO 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). who.int/biologicals/areas/biological-therapeutic/BIOTHERAPETUTICS-FOR- WEB-22APRIL2010-WI. Accessed August 18, 2010.
15. United States Government. 111th Congress of the United States of America. The Patient Protection and Affordable care Act. HR 3590. March 2010. http://democrats.senate.gov./reform/patientprotection-affordable-care-act-as- passed.pdf. Accessed June 11, 2010.