03N-0205
BKG 1
Volume 1

Table of Contents

1. Hendeles, L. et al., "Treatment Failure After Substitution of Generic Pancrelipase Capsules: Correlation with In Vitro Lipase Activity," Journal of the American Medical Association, 263:2459-2461, 1990.

2. Regan, P. T. et al., "Comparative Effects of Antacids, Cimetidine and Enteric Coating on the Therapeutic Response to Oral Enzymes in Severe Pancreatic Insufficiency," New England Journal of Medicine, 297:854-858, 1977.

3. Graham, D. Y., "Enzyme Replacement Therapy of Exocrine Pancreatic Insufficiency in Man: Relation Between In Vitro Enzyme Activities and In Vivo Potency in Commercial Pancreatic Extracts, 'I New England Journal of Medicine, 296:1314-1317, 1977.

4. Fatmi, A. A., and J. A. Johnson, "An In Vitro Comparative Evaluation of Pancreatic Enzyme Preparations, m Drug Development and Industrial Pharmacy, 14:1429-1438, 1988.

5. Graham, D. Y. "An Enteric-Coated Pancreatic Enzyme Preparation that Works," Digestive Diseases and Sciences, 24:906-909, 1979.

6. Mischler, E. H. et al., "Comparison of Effectiveness of Pancreatic Enzyme Preparations in Cystic Fibrosis," American Journal of Diseases of Children, 136:1060-1063, 1982.

7. Littlewood, J. M. et al., "In Vivo and In Vitro Studies of Microsphere Pancreatic Supplements, '1 Journal of Pediatric Gastroenterology and Nutrition, 7 (Supplement T):S22-S29, 1988.

8. Dutta, S. K., V. S. Hubbard, and M. Appler, "Critical Examination of Therapeutic Efficacy of a pH-Sensitive Enteric-Coated Pancreatic Enzyme Preparation in Treatment of Exocrine Pancreatic Insufficiency Secondary to
Cystic Fibrosis," Digestive Diseases and Sciences, 33:1237-1244, 1988.

9. Beverley, D. W. et al., "Comparison of Four Pancreatic Extracts in Cystic Fibrosis," Archives of Disease in Childhood, 62:564-568, 1987.

10. Cystic Fibrosis Foundation Results of a Survey of 114 Cystic Fibrosis Care Centers in United States, Patient Registry 1992 Annual Data Report, Bethesda, MD, October 1993, in OTC Vol. 17BFR, Docket No. 79N-0379, Dockets Management Branch.

11. Smyth, R. L. et al., "Strictures of Ascending Colon in Cystic Fibrosis and High-Strength Pancreatic Enzymes," Lancet, 343:85-86, 1994.

12. Oades, P. J. et al., "Letter to the Editor," Lancet, 343:109, 1994.

13. Campbell, C. A., J. Forrest, and C. Musgrove,' "Letter to the Editor," Lancet, 343:109, 1994.

14. Briars, G. L. et al., "Letter to the Editor," Lancet, 343:600, 1994.

15. Mahony, M. J. and M. Corcoran, "Letter to the Editor," Lancet, 343:599-600, 1994.

16. Knabe, N. et al., "Letter to the Editor," Lancet, 343:1230, 1994.

17. Taylor, C. J. "Colonic Strictures in Cystic Fibrosis," Lancet, 343:615-616, 1994.

18. Letter dated February 14, 2001, from P. W. Campbell, III, Cystic Fibrosis Foundation, to L. Talarico, FDA.