04P-0231
C 1
Volume 4

Cover Letter

Table of Exhibits

1. Pfizer, Inc., Exhibit for 10K for Fiscal Year 2003, U.S. SEC (filed March 10, 2004), Exhibit 13, 2003 Financial Report at 50

2. Genentech v. Bowen, 676 F. Supp. 301 (D.D.C. 1987)

3. Genentech v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997), cert. denied, 522 U.S. 963 (1997)

4. Novo Nordisk A/S et al. v. Bio-Technologv General Corn., Ltd.. et al., 2003 U.S. Dist. LEXIS 10098 (D. Del., June 9, 2003)

5. Pharmacia Genotropin Human Growth Hormone Launch Set For Early 1996, F-D-C Reports, The Pink Sheet, 57(36):(Sept. 4, 1995), at T&G-10

6. Bio-Technology General Bio-Tropin Preliminary Injunction Upheld, F-D-C Reports, The Pink Sheet, 58(16):(April 5,1996), T&G-3-T&G-4

7. Serono Saizen Human Growth Hormone Approved With Three-Times Weekly Dosing Schedule; Somatropin Product Labeling Carries Hypothyroidism Precaution, F-D-C Reports, The Pink Sheet, 58(42):(October 14, 1996), at 6

8. Pharmacia & Upjohn, Inc., Pre-Effective Amendment No. 2 to Form S-4, As Filed With The Securities And Exchange Commission on September 15, 1995, at 136

9. Generic Somatropin NDAs Would Require Human Immunogenicity Tests - FDA, F-D-C Reports, The Pink Sheet, 64(16): (April 22, 2002), at 14

10. European Pharmacopoeia at 1940-1942, Somatropin Bulk Solution Monograph No. 01/2002:0950

11. European Pharmacopoeia at 1937-1939, Somatropin Monograph No. 01/2002:0951

12. European Pharmacopoeia at 1942-1944, Somatropin for Injection Monograph No. 01/2002:0952

13. European Directorate For The Quality Of Medicines, European Pharmacopoeia Commission, PA/PH/Exp. 6/T (03) 42 ANP, Group Of Experts No. 6 (Biological Substances), Somatropin bulk solution, Monograph No: 950 (Dec. 2003)

14. European Directorate For The Quality Of Medicines, European Pharmacopoeia Commission, PA/PHYExp. 6/T (03) 43 ANP, Group Of Experts No. 6 (Biological Substances), Somatropin, Monograph N° 951 (Dec. 2003)

15. European Directorate For The Quality Of Medicines, European Pharmacopoeia Commission, PA/PH/Exp. 6/T (03) 44 ANP, Group Of Experts No. 6 (Biological Substances), Somatropin for Injection, Monograph No: 952 (Dec. 2003)

16. USP, 25 Pharmacopeial Forum 8540-8552 (July-Aug. 1999), In-Process Revisions for Somatropin and Somatropin for Injection

17. USP, 29 Pharmacopeial Forum 1978-1984 (Nov.-Dec. 2003), In-Process Revisions for Somatropin and Somatropin for Injection.

18. Public Citizen Health Research Group v. FDA, 964 F. Supp. 413,415 (D.D.C. 1997).

19. Steve Usdin, Breaking Ranks, 12 BioCentury Al-A3 (June 21, 2004).

20. Comments of the Biotechnology Industry Organization Re: Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation (April 18, 2001).

21. Comments of the Biotechnology Industry Organization Re: Recombinant DNA Research, Proposed Actions Under the NIH Guidelines (Feb. 12, 2001).

22. 505(b)(2) NDA Inventory

23. Pfizer, Inc., Policy on Public Disclosure of Clinical Trial Results, Section 3.1. Communication of Results by Pfizer

24. Pfizer Inc., Notice of Annual Meeting of Shareholders and Proxy Statement (Mar. 17, 2003).

25. Pfizer Code of Business Conduct and Ethics for Directors.

26. SO Fed. Reg. 21460 (May 24, 1985)

27. SO Fed. Reg. 31887 (Aug. 7, 1985)

28. Letter to the Drug Industry by Dr. Paul D. Parkman, then-Acting Director of the Center for Drugs and Biologics (1987)

29. FDA Consolidated Response to Pfizer et al. Petitions, FDA Docket Nos. 2001P-0323/CP1 & CS, 2002P-0447/CP1, and 2003P-0408/CP1

30. FDA Docket No. 85N-0214, Vol. 1, C21, Letter from James C. Shehan, Pfizer, to Dockets Management Branch (HFA-305) (Jan. 8, 1990) at 21-22

31. Letter from Marvin R. Frank, Pharm.D., J.D., Pfizer, to Mr. Gerald F. Meyer, FDA (June 5, 1990), accompanying RCl, FDA Docket No. 93P-0115 (April 22, 1993), filed in FDA Docket No. 85N-0214 (May 26, 1993)

32. FDA Approval Letter for Novo Nordisk’s GlucaGen (glucagon [rDNA origin] for injection) (June 22, 1998)

33. Serono Laboratories, Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998)

34. Draft Guidance for Industry: Applications Covered by Section 505(b)(2), FDA Docket No. 99D-4809 (Oct. 1999)

35. FDA Docket No. 99D-4809, Cl (Feb. 7,2000) (Fax Message from Kathleen M. Sanzo to FDA Dockets Management Branch)