Join the 'Creon' group to help and get support from people like you.
Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Posted 14 Jun 2011 by Drugs.com
First infant-specific dosage strength now approved by the FDA ABBOTT PARK, Ill., June 14, 2011 /PRNewswire/ – Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved 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. This new option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing. Most infants with CF require small doses of pancreatic enzyme replacement therapy (PERT) with every feeding. Until now, parents or caregivers administering an infant dose of PERT have had to open a capsule of a larger dose and measure out a portion of the contents. The new 3,000 units of lipase capsule ... Read more