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FDA Gives Approval to Abbott Infant Doses of Creon


An infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules has been given approval by the U.S. Food and Drug Administration.

CREON, manufactured by Abbott Products, Inc., is used to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The new infant-specific dose of CREON will contain 3,000 units of lipase capsule, providing the lowest dosage strength in the class approved by the FDA.

The new infant-specific dose option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing.

To achieve infant-appropriate dosing, parents or caregivers have had to open adult capsules and measure out a portion of the contents. Not a very precise or accurate method.

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Cystic fibrosis (CF) is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States and nearly 70,000 people worldwide. CF causes life-threatening lung infections and serious digestive complications.

EPI makes it impossible for the individual to properly digest food due to the deficiency of pancreatic enzymes, which may lead to malnutrition. The pancreatic enzymes in CREON capsules work directly in the intestines to help break down fats, proteins and carbohydrates, allowing the body to better digest nutrients from food.

The pancreatic enzymes are needed with each meal. The infant-specific doses of CREON will make it easier on parents and caregivers to give the appropriate dose of pancreatic enzyme replacement therapy (PERT) with every feeding.

″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 United States, providing improved dosing titration options and flexibility into adulthood."

CREON is dosed by lipase units and is available in four lipase unit strengths (3,000 / 6,000 / 12,000 / 24,000 units of lipase).

Cystic Fibrosis Foundation