2005P-0095
Volume 1
CP 1

Citizen Petition

Exhibit 1 - Federal Register, from Wednesday, June 26, 1968 at 33 Fed. Reg. 9352.

Exhibit 2 - Lawrence R: “Development and Comparison of Iron Dextran Products.” PDA J. Pharm. Sci. Technol., 52: 190-197, 1998.

Exhibit 3 - Review by FDA’s Division of Bioequivalence of the pharmacokinetics and iron utilization studies performed for DEXFERRUM’s approval as 505b(2) application.

Exhibit 4 - November 6, 2000, FDA approval letter

Exhibit 5 - Journal of Inorganic Biochemistry 98: 1757-1769, 2004.

Exhibit 6 - Arzneim.-Forsch./Drug Res.42(II), 12: 1439-1452, 1992.

Exhibit 7 - Funk F, et al: "Physical and Chemical Characterization of Therapeutic Iron Containing Materials: A Study of Several Superparamagnetic Drug Formulations with the B-FeOOH or Ferrihydrite Structure." Hyperfine Interactions 136: 73-95, 2001.

Exhibit 8 - Certificates of Analysis

Exhibit 9 - Sato K, et al: "Saccharate Ferric Oxide (SFO) - Induced Osteomalacia: In Vitro Inhibition by SFO of Bone Formation and 1,25-Dihydroxy - Vitamin D Production in Renal Tubules." Bone 21(1): 57-64, 1997.

Exhibit 10 - Sato K and Shiraki M: "Saccharated Ferric Oxide - Induced Osteomalacia in Japan: Iron-Induced Osteopathy due to Nephropathy." Endo. J. 45(4): 431-439, 1998.

Exhibit 11 - Report by WHO Collaborating Centre Drug Monitoring.

Exhibit 12 - Geisser, P. Iron Therapy, Oxidative Stress and Immunology, 2004, edited by Chandra, RK. Nutrition and Immunology in the 21st Century, TSAR Health India.

Exhibit 13 - Mehta, BC. J. Assoc. Physicians India JAPI, 51:419-421, 2003.

Exhibit 14 - Sunder-Plassmann G and Horl W H: “Safety of Intravenous Injection of Iron Saccharate in Haemodialysis Patients.” Nephrol. Dial. Transplant 11: 1797-1802, 1996.

Exhibit 15 - Fletes R, Lazarus JM, Gage J, Chertow GM, "Suspected Iron Dextran-Related Adverse Drug Events in Hemodialysis Patients." Am J Kidney Dis. 2001 37(4): 742-749, 2001.

Exhibit 16 - Notice to Physicians dated November 16, 1995 on FERRLICIT

Exhibit 17 - See Docket 00D-0835, Draft Guidance for Industry on Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Availability, 65 Fed. Reg. 12556 (March 9, 2000).