Considering the commonness of digestive disorders, new drugs could be duly welcome in the medical arena. On this note, the US Food and Drug Administration (FDA) has approved 2 new pancreatic enzyme products namely Ultresa and Viokace for helping in digestion of food.
Ultresa is a delayed-released capsule used for the treatment of cystic fibrosis in children. Usually, patients suffering from this condition are not able to digest food the normal way as their pancreas cannot make adequate enzymes.
Alternately, Viokace is used in combination with a proton pump inhibitor to digest food in the normal manner. Adults who are affected by chronic pancreatitis, face difficulty in digesting food as they lack critical enzymes or because the enzymes are not delivered to the bowel. However, the effectiveness and safety of this medication in children has not been affirmed.
“The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency,” cited Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.
With this approval, both these products join the league of other pancreatic enzyme products such as Pancreaze, Creon and Zenpep. Unapproved pancreatic enzyme products had been in use since many years, after which the FDA issued a notice on April 28, 2010 to stop distribution of unapproved products.
Bridgewater markets Ultresa and Viokace.