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ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.
Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.
Most infants with the disease require small doses of pancreatic enzyme replacement therapy with every feeding, but parents or caregivers previously had to open a capsule and measure out a portion of the contents. The new capsule will allow them to provide a more precise dose.
“We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis,” Abbott VP global pharmaceutical development Eugene Sun said. “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.”