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SYNTHETIC SECRETINS
Secretin is a gastrointestinal peptide hormone that was first identified by Jorpes and Mutt in 1961. Secretin and other members of the VIP family of peptides have been studied and reported in the literature. The primary FDA approved clinical indications for the previous marketed porcine secretin were:1) Exocrine Pancreas Function Test; 2) Zollinger-Ellison Syndrome Test, and 3) Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangio-pancreatography (ERCP). Synthetic Porcine Secretin H-His-Ser-Asp-Gly-Thr-Phe-Thr-Ser-Glu-Leu-Ser-Arg- Leu-Arg-Asp-Ser-Ala-Arg-Leu-Gln-Arg-Leu-Leu-Gln- Gly-Leu-Val-NH2 MW 3055.5 CAS# 17034-35-4 NDA submitted May, 1999; First approvable letter March, 2000; Second approvable letter November, 2000. NDA Approval April 5, 2002. ChiRhoClin will continue to be responsible for manufacturing, medical, regulatory activities, marketing and distribution. Synthetic Human Secretin H-His-Ser-Asp-Gly-Thr-Phe-Thr-Ser-Glu-Leu-Ser-Arg- Leu-Arg-Glu-Gly-Ala-Arg-Leu-Gln-Arg-Leu-Leu-Gln- Gly-Leu-Val-NH2 MW 3039.4 CAS# 108153-74-8 NDA Submitted March, 2000; NDA amendment June, 2001. Approvable letter received on December 14, 2001. Human Secretin NDA Approved on April 9th, 2004 ChiRhoStim® (Human Secretin for Injection) is approved, for the diagnostic indications of exocrine pancreas function test, facilitated cannulation during ERCP procedures, and Zollinger-Ellison Syndrome test. Dosing and Reconstitution Procedure ChiRhoStim® (Human Secretin for Injection) is reconstituted with eight (8) mL of saline for injection. After reconstitution, the resulting solution should be used within 60 minutes. One ( 1 ) microgram ( mcg ) of Synthetic Human Secretin is approximately equal to five ( 5 ) clinical units ( CU ). Dosing Exocrine Pancreas Function testing: -Dose 0.2 mcg/kg Zollinger - Ellison Syndrome testing: -Dose 0.4 mcg/kg |
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