1. US Food and Drug Administration. FDA approves first generic enoxaparin sodium injection. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm (Accessed 24 January 2012).
2. Hirsh, J. et al. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest 119, 64S–94S (2001).
3. 21 CFR 320.1(c). (Code of Federal Regulations; Title 21, Food and drugs; Part 320, Bioavailability and bioequivalence requirements; FDA HHS, 2012).
4. 21 CFR 320.1(e). (Code of Federal Regulations; Title 21, Food and drugs; Part 320, Bioavailability and bioequivalence requirements; FDA HHS, 2012).
5. 21 CFR 320.22(b)(1). (Code of Federal Regulations; Title 21, Food and drugs; Part 320, Bioavailability and bioequivalence requirements; FDA HHS, 2012).