Ultresa (pancrelipase) and Viokace (pancrelipase), two pancreatic enzyme products marketed by Aptalis Pharma U.S. Inc., were approved on March 1 by the FDA. The products, intended to aid food digestion, are the fourth and fifth pancreatic enzyme products approved by the FDA, and, according to the agency, will help ensure adequate supply of the medications.

Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis or other conditions that prevent patients from digesting food normally because of exocrine pancreatic insufficiency. Viokace, taken in combination with a proton pump inhibitor, is used to treat adults who cannot digest food normally, including those with chronic pancreatitis or those who have had a pancreatectomy. Viokace’s safety and efficacy in children has not been established.

“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,” Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, Beltsville, Md., said in a statement.

Unapproved pancreatic enzyme products had been available for decades; however, as of April 28, 2010, the manufacture and distribution of unapproved pancreatic enzyme products was no longer permitted by the FDA. Besides Ultresa and Viokace, Creon (Abbott Laboratories), Pancreaze (Janssen Pharmaceuticals, Inc.) and Zenpep (Eurand Pharmaceuticals, Inc.) are also approved by the FDA.