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Back To News: ChiRhoStim® (Human Secretin for Injection) FDA approved labeling update and 5-year shelf life approval
ChiRhoStim® (Human Secretin for Injection) FDA approved labeling update and 5-year shelf life approval
[Jul 25, 2017]

ChiRhoClin, Inc. is pleased to notify the medical community that ChiRhoStim® (Human Secretin for Injection) has received FDA approval, updating its package insert. There are two significant changes to the package insert.  The first change eliminates the need to inject a test dose prior to administering ChiRhoStim®.  The second significant change is the removal of the contraindication section.  The benefit for patients experiencing an acute pancreatitis episode is that they can be administered ChiRhoStim® for pancreatic evaluation. These two changes to the package labeling may shorten procedure time and patient treatment.  In addition, an extended 5-year shelf life of ChiRhoStim® was approved. This shelf life extension of the product stability will provide a steady stream of Secretin for the future.

 

ChiRhoStim® is an orphan drug product that aids in the diagnoses of pancreatic cancer and pancreatic exocrine dysfunction.  ChiRhoStim® is approved for pancreatic function testing, facilitating cannulation during ERCP, and Gastrinoma testing.  In addition, secretions of the pancreatic fluid after secretin stimulation can be used in situ for imaging modalities such as MRCP, CT, and EUS.

 

Skip Purich, C.O.O., said “These improvements to our product shelf life and updated labeling will assist the medical community in shortening Gastroenterology and Radiology procedure times.  As well as not delaying diagnostic testing such as secretin stimulated MRCP (SMRCP) or function testing while a patient is suffering from acute pancreatitis.”        

 

ChiRhoClin, Inc., a Maryland based family run corporation founded in 1991 by Dr. Edward D. Purich, is a research and development oriented pharmaceutical company focused on developing orphan drug products for the gastrointestinal and radiological community.  Our emphasis is to develop orphan drug products that will diagnose and treat pancreatic gastrointestinal diseases and encourage research in the pancreatic area through our small pancreatic grant program.

 

If you would like more information on ChiRhoStim® (Human Secretin for Injection), please visit www.ChiRhoStim.com or call 1-877-272-4888.