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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Synthetic human secretin
Trade Name: Chirostim
Date Designated: 06/16/1999
Orphan Designation: For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.
Orphan Designation Status: Designated/Approved
ChiRhoClin, Inc.
15500 Gallaudet Ave.
Silver Spring, Maryland 20905
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Synthetic human secretin
Trade Name: Chirostim
Marketing Approval Date: 04/09/2004
Approved Labeled Indication: Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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