ChiRhoClin, Inc. announces the availability of ChiRhoStim® (Human Secretin for injection) to the medical community.
(Burtonsville, Maryland) ChiRhoStim® (Human Secretin for injection) is now commercially available to the medical community. ChiRhoStim® batch #0636149 was manufactured in June 2013 in a new manufacturing facility and has met all product release and sterility tests. This new facility must be approved by the FDA before new ChiRhoStim® batches can be manufactured. In the interim, the FDA is permitting the release of batch #0636149 provided there is an additional level of assurance to protect against any theoretical possibility of microbiological contamination.
ChiRhoClin is instructing all medical personnel administering ChiRhoStim® to use the Millex-GV syringe microbial filter unit (0.22 μm, PVDF, 33 MM, GAMMA STERILIZED) prior to administering ChiRhoStim® for batch #0636149. Each shipment of this ChiRhoStim® batch will include a filter, instructions on how to use the filter, and a dear healthcare professional letter.
For details on how to use the filters, please visit www.ChiRhoStim.com.
Many patients have been in desperate need of this diagnostic drug product and ChiRhoClin feels privileged to help serve this patient population. Dr. Purich stated that, “It took many interactions with the agency to resolve this critical shortage. We are thankful for CDER and the Drug Shortage Team for working so diligently to help make ChiRhoStim® available. We would also like to thank the patients and medical community for all of their support and understanding during this time.”
ChiRhoStim® is an orphan drug that diagnoses pancreatic exocrine dysfunction and Zollinger-Ellison syndrome (Gastrinoma). ChiRhoStim® stimulates the pancreas to produce pancreatic fluid in fasted patients. The resulting pancreatic fluid can be observed dynamically using many imaging modalities such as MRCP, CT, and EUS. In addition, the pancreatic fluid can be used to assay bicarbonate, electrolytes, and other genetic and proteomic endmarkers.
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 pancreatic grant program.
If you have any questions on ChiRhoStim® availability, filters, indications or stability, please contact Skip Purich C.O.O. at 301-476-8388. ChiRhoStim® is available by ordering directly through our toll free number: 1-877-272-4888.
For more information, please visit www.ChiRhoStim.com