Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis

Confirmed PEI by historical CFA \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months)

Subjects of 12 years or older

Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months

Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis