03P-0275
REF 1
Volumes 2-6

Index
1. Letters from Sandoz, Inc. to FDA
Dated: 7/29/82

2. Letter from FDA to Sandoz, Inc. re NDA 50-573 and NDA 50-574
Dated: 11/14/83

3. Memorandum from James Ramsey, Ph.D. to Murray Lumpkin, M.D. re Cyclosporine - Request for Reclassification
Dated: 12/15/94

4. Letter from FDA to Sandoz Pharmaceuticals Corp.
Dated: 4/19/95

5. Letter from Novartis to FDA
Dated: 3/19/97

6. Memorandum from James Ramsey, Ph.D. to Murray Lumpkin, M.D. re Antimicrobial Activity of Lovastatin and Related Drugs
Dated: 8/1/97

7. Letter from FDA to Allergan, Inc. and Product Labeling
Dated: 12/23/02

8. Letter from FDA to Allergan, Inc.
Dated: 3/3/03

9. Citizen Petition filed by Fish & Richardson (received 6/16/03)
Dated: 6/l 3/03

10. Letter from FDA to Fish & Richardson
Dated: 6/17/03

11. Petition for Stay filed by Fish & Richardson
Dated: 8/1/03

12. Amendment to Citizen Petition filed by Fish & Richardson
Dated: 8/1/03

13. Letter from FDA to Fish & Richardson
Dated: 8/6/03

14. Administrative Record for FDA’s classification of Periostat (doxycycline hyclate) 20 mg as an antibiotic drug
Dated: 9/23/03


Tab A, part 2, part 3, part 4, part 5, part 6
Tab B, part 2, part 3, part 4, part 5, part 6, part 7, part 8, part 9, part 10, part 11, part 12, part 13, part 14, part 15, part 16
Tab 16, continued
Tab 17
Tab 18
Tab 19
Tab 20
Tab 21
Tab 22
Tab 23
Tab 24
Tab 25
Tab 26
Tab 27
Tab 28
Tab 29
Tab 30
Tab 31
Tab 32
Tab 33
Tab 34


15. Letter from Arnold & Porter to FDA
Dated: 10/24/03
, continued
16. Memorandum from David Roeder and Edward Cox, M.D., M.P.H., to NDA 50-790 Restasis (cyclosporine) re Review of Administrative Record Related to the Classification of Antibiotic Drugs Approved for Non-Antimicrobial Indications
Dated: 12/18/03
, continued
17. Excerpts from Electronic Approved Drug Products with Therapeutic Equivalence Evaluations for cyclosporine
Printed: 12/18/03

18. Product Labeling for Sandimmune
19. Excerpts from electronic Approved Drug Products with Therapeutic Equivalence Evaluations and Product Labeling for tacrolimus and mycophenolate
Printed: 12/18/03
, continued
20. Excerpts from electronic Approved Drug Products with Therapeutic Equivalence Evaluations and Product Labeling for ciprofloxacin, levofloxacin, and trovafloxacin
Printed: 12/18/03

21. Excerpts from electronic Approved Drug Products with Therapeutic Equivalence Evaluations for bleomycin, daunorubicin, doxorubicin, epirubicin, mitomycin, and plicamycin; and Product Labeling for bleomycin, daunorubicin, and doxorubicin
Printed: 12/18/03

22. Product Labeling for lovastatin
23. Excerpts from electronic Approved Drug Products with Therapeutic Equivalence Evaluations for approved New Drug Applications for prescription drug products held by Allergan, Inc.
Printed: 12/18/03

24. Section 507 of the Act, 21 U.S.C. 8 357 (repealed)
25. Section 125 of the Food and Drug Administration Modernization Act
26. Guidance for Industry and Reviewers, Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act
Dated: 5/98

27. Marketing Exclusivity and Patent Provisions for Certain Antibiotic Drugs; Proposed Rule, 65 Fed. Reg. 3623 (Jan. 24, 2000)
28. Excerpts from Parts 430,436, and 448 of Title 21 of the Code of Federal Regulations (antibiotic drugs; general) (1985)
29. Excerpts from electronic Approved Drug Products with Therapeutic Equivalence Evaluations for Sandimmune capsule 25 mg, Sandimmune capsule 50 mg, and Sandimmune capsule 100 mg
Printed: 12/18/03

30. Excerpts from Hearings Before the Senate Committee on Labor and Human Resources, 105th Cong., 1st Sess. (Mar. 19 and Apr. 11, 1997)
31. Excerpts from H.R. Rep. No. 702, 79th Cong. (1945)
32. Excerpts from S. Rep. No. 448, 87th Cong. 1st Sess. (1961)
33. Excerpts from Hearings Before a Subcommittee of the Committee on Interstate and Foreign Commerce on H.R. 3 15 1, H.R. 562, and H.R. 160,81st Cong., 1st Sess. (Apr. 12 and 18, and May 2, 1949)
34. Excerpts from Hearings Before the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary on S. 1552, 87th Cong., 1st Sess. (1961)
35. 143 Cong. Rec. H8479 (Oct. 7, 1997)
36. 143 Cong. Rec. H10531-H10478 and S12241-S12252 (Nov. 9, 1997)
37. Hearings Before House Committee on Interstate and Foreign Commerce on Drug Industry Act of 1962, 87th Cong., 2d. Sess. (Aug. 20, 1962), part 2, part 3
38. Hearings Before House Committee on Interstate and Foreign Commerce on Drug Industry Act of 1962, 87th Cong., 2d. Sess. (Aug. 22, 1962), part 2, part 3
39. Letter from FDA to Fish & Richardson and Arnold & Porter (Response to Citizen Petition)
Dated: 12/18/03