ChiRhoClin, Inc. Announces Secretin Drug Shortage Resolved
BURTONSVILLE, Md., July 28, 2015 /PRNewswire/ — During the past 5 years, ChiRhoClin, Inc. has worked directly with the Food and Drug Administration, CDER, the Drug Shortage Team, and the Office of Pharmaceutical Quality (OPQ) to resolve the shortage of ChiRhoStim® (Human Secretin for Injection). Today we received notice that our contract manufacturing facility has been approved to manufacture ChiRhoStim®. ChiRhoClin has secured the manufacturer to produce ChiRhoStim® for over a decade. ChiRhoStim® is officially off the drug shortage list with a large supply of commercially available product. Skip Purich commented, “With the FDA approval of ChiRhoClin’s contract manufacturer, we can once again provide an uninterrupted supply of ChiRhoStim® to the medical community.”
Many patients have been in desperate need of this diagnostic drug product. We feel privileged to help serve this patient population. Dr. Purich said, “It took a great deal of persistence and many interactions with the agency to resolve this critical shortage. We are thankful to CDER, the Drug Shortage Team, and OPQ for working so diligently to help resolve these issues.”
ChiRhoStim®, an orphan drug, diagnoses diseases of the pancreas including pancreatic exocrine dysfunction and Zollinger-Ellison syndrome (Gastrinoma). ChiRhoStim® is used to stimulate the pancreas to produce pancreatic fluid for function testing. The resulting pancreatic fluid can be observed dynamically using imaging modalities such as MRCP, CT, and EUS. You can also collect pancreatic fluid for clinical tests such as bicarbonate, electrolytes, genetic and proteomics profiling.
ChiRhoClin looks forward to supplying ChiRhoStim® to the medical community. In addition, we will reinitiate our clinical trials and grant programs that have been postponed until the supply was stabilized. ChiRhoClin would also like to thank the patients and medical community for all their support and understanding during the drug shortage.
If you have any questions on the availability of ChiRhoStim®, its indications or stability, please contact Skip Purich C.O.O. at 301-476-8388. ChiRhoStim® is available by ordering direct or through wholesalers. For more information please visit www.ChiRhoStim.com or call 1-877-272-4888.