FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


2005P-0322
CP 1
Volume 1

Citizen Petition

Attachment 1 - Rosenfeld RG, Rosenbloom AL, Guevara-Aguirre J. Growth hormone (GH) insensitivity due to primary GH receptor deficiency. Endocr. Rev. 1994 Jun; 15(3): 369-390 Published Material

Attachment 2 - Tercica, 10-K Annual Report, 6-7 (Mar. 24, 2005) (available at http://www.shareholder.com/Common/Edgar/1262175/1193125-05-59908/05-00.pdf

Attachment 3 - Tercica Press Release, "Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-I Deficiency," (Feb. 28, 2005) (available at http://investor.tercica.com/releases.cfm Published Material

Attachment 4 - Tercica, Press Release, "FDA Accepts Tercica’s Increlex New Drug Application With Priority Review for the Treatment of Short Stature" (May 2, 2005) (available at http://investor.tercica.com/releases.cfm) Published Material

Attachment 5 - Ratner ML. Tercica: growing small. Start-Up: Windhover’s Review of Emerging Medical Ventures. 2004 Dec; 9(11): 13-18 Published Material

Attachment 6 - Firth SM, McDougall F, McLachlan AJ, Baxter RC. Impaired blockade of insulin-like growth factor I (IGF-I)-induced hypoglycemia by IGF binding protein-3 analog with reduced ternary complex-forming ability. Endocrinology 2002 May; 143(5): 1669-76 Published Material

Attachment 7 - Guler HP, Zapf J, Froesch ER. Short-term metabolic effects of recombinant human insulin-like growth factor I in healthy adults. N Engl J Med. 1987 Jul 16; 317(3): 137-40 Published Material

Attachment 8 - F-D-C Reports, Inc., "The Pink Sheet" 65(51): 20 (Dec. 22, 2003). Symlin "Approvable" Letter Will Be Addressed By Ongoing Trials, Amylin Says Published Material

Attachment 9 - Underwood L, Chernausek SD, Kuntze J, Frane J, Bright GM. Efficacy of long-term treatrnent with recombinant human IGF-I (rhIGF-I) of children with GH insensitivity [abstract no. P3-451]. Presented at: The Endocrine Society’s 86th Annual Meeting, New Orleans, June 2004

Attachment 10 - Chernausek, SD, Underwood L, Kuntze J, Frane J, Bright GM. Safety of recombinant human IGF-I in the treatment of children with IGF-I deficiency due to GH insensitivity: 231 treatment-years of experience [poster]. Presented at: The Endocrine Society’s 86th Annual Meeting, New Orleans, June 2004

Attachment 11 - Backeljauw PF, Underwood LE; GHIS Collaborative Group. Prolonged treatment with recombinant insulin-like growth factor-I in children with growth hormone insensitivity syndrome- a clinical research center study. J Clin Endocrinol Metab. 1996 Apr; 81(9): 3312-17 Published Material

Attachment 12 - Underwood LE, Backeljauw P, Duncan V, GHIS Collaborative Group. Effects of insulin-like growth factor I treatment on statural growth, body composition and phenotype of children with growth hormone insensitivity syndrome. Acta Paediatr Suppl. 1999; 428: 182-184 Published Material

Attachment 13 - Backeljauw PF, Underwood LE, GHIS Collaborative Group. Therapy for 6.5-7.5 years with
recombinant insulin-like growth factor I in children with growth hormone insensitivity syndrome: a clinical research center study. J Clin Endocrinol Metab. 2001;86(4): 1504-1510 Published Material

Attachment 14 - Clark R, Frane J. and Bright, G. Long-term Therapy with rhIGF-I: No evidence of Neutralizing Antibodies [poster P1-493]. Presented at: The Endocrine Society’s 87th Annual Meeting, San Diego, June 2005

Attachment 15 - Ranke MB, Savage MO, Chatelain PG, Preece MA, Rosenfeld RG, Blum WF, et al. Insulin-like growth factor I improves height in growth hormone insensitivity: two years’ results. Horm Res. 1995; 44(6): 253-264 Published Material

Attachment 16 - Guevara-Aguirre J., et al. A randomized, double blind, placebo-controlled trial on safety and efficacy of recombinant human insulin-like growth factor-I in children with growth hormone receptor deficiency. J Clin Endocrinol Metab. 1995 Apr; 80(4): 1393-8 Published Material

Attachment 17 - Guevara-Aguirre J, Rosenbloom AL, Vasconez O, Martinez V, Gargosky SE, Allen L, et al. Two-year treatment of growth hormone (GH) receptor deficiency with recombinant insulin-like growth factor I in 22 children: comparison of two dosage levels and to GH-treated GH deficiency. J Clin Endocrinol Metab. 1997 Feb; 82(2): 629-633 Published Material

Attachment 18 - Malozowski S, Tanner LA, Wysowski D, Fleming GA. Growth hormone, insulin-like growth factor I, and benign intracranial hypertension [letter]. N Engl J Med. 1993; 329(9): 665-666 Published Material

Attachment 19 - Malozowski S, Stadel B. Risks and benefits of insulin-like growth factor [letter]. Ann Int Med. 1994; 121(7): 549-550 Published Material

Attachment 20 - The DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329: 977-86 Published Material

Attachment 21 - The DCCT Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes 1997; 46: 271-86 Published Material

Attachment 22 - Genuth S. Exogenous insulin administration and cardiovascular risk in non-insulin-dependent and insulin-dependent diabetes mellitus. Ann Intern Med. 1996; 124: 104-9 Published Material

Attachment 23 - Tercica, S-1 Registration Statement, at 8 (Sept. 12, 2003) (available at
http://www.sec.gov/Archives/edgar/data/1262175/000119312503048598/dsl.htm


Top | Back

Page last updated August 19, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management