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Brief Report

Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers

Pages 1653-1657 | Accepted 14 Jun 2011, Published online: 30 Jun 2011

References

  • KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47:S11-145
  • Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med 2005;352:1011-23
  • Coyne DW, Kapoian T, Suki W, et al. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients’ Response to IV Iron with Elevated Ferritin (DRIVE) study. J Am Soc Nephrol 2007;18:975-84
  • Nissenson AR, Lindsay RM, Swan S, et al. Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American Clinical Trial. Am J Kidney Dis 1999;33:471-82
  • Ferrlecit [prescribing information]. Bridgewater, NJ, USA: sanofi-aventis US LLC, 2010
  • Nulecit [prescribing information]. Corona, CA, USA: Watson Pharma Inc., 2010
  • Center for Drug Evaluation and Research. U.S. Food and Drug Administration. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. 2001

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