Abbott received approval from the FDA for an infant-specific dose of Creon (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The Creon 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA, representing a new option for more precise dosing for infants with CF.

“We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis,” said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. “This approval means that CREON will now be available in four dosing options, including both the lowest and highest dosage strengths available to patients in the U.S., providing improved dosing titration options and flexibility into adulthood.”