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Creon 5 News

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

Related support groups: Creon, Pancreatic Exocrine Dysfunction, Creon 10, Creon 20, Creon 5

Abbott Receives FDA Approval for Creon to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy

Posted 5 May 2010 by Drugs.com

ABBOTT PARK, Ill.., May 3 /PRNewswire-FirstCall/ – Abbott (NYSE:ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.   Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Patients with chronic pancreatitis or those who have had their pancreas removed (to manage conditions of the pancreas such as CP, pancreatic cancer or ... Read more

Related support groups: Pancreatitis, Creon 10, Creon 20, Creon 5

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Further Information

Related Condition Support Groups

Chronic Pancreatitis, Pancreatic Exocrine Dysfunction, Cystic Fibrosis

Related Drug Support Groups

Creon, Pancrease, Zenpep, Creon 10, Pancreaze, Viokase, Creon 20, Ultrase, Ultrase MT 20, view more... Pancrease MT 20, Cotazym, Ultrase MT 12, Pancrease MT 10, Pancrease MT 4, Panokase, Viokace, Creon 5, Viokase 16, Viokase 8, Panase, Pancrease MT 16, Pancreatil-UL 12, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Pancron D / R, Lapase, Pangestyme CN 10, Pangestyme CN 20, Pangestyme EC, Pangestyme MT 16, Pancrease MT, Arco-Lase, Pangestyme UL 18, Pangestyme UL 20, Cotazym-S, Panocaps, Panocaps MT 16, Panokase 16, Protilase, Protilase MT-16, Ilozyme, Ultresa, Lipram UL, Encron-10, Ultrase MT 18, Lipram, Lipram-CR, Lipram-CR10, Lipram-CR20, Lipram-CR5, Lipram-PN10, Lipram-PN16, Lipram-PN20, Lipram-UL 12, Lipram-UL 18, Lipram-UL 20, Plaretase, Zymase, Pancrecarb MS, Ku-Zyme, Pertzye, Ku-Zyme HP, Dygase, Kutrase, Palcaps 10, Vio-Moore

Creon 5 Patient Information at Drugs.com