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Creon Approval History

  • FDA approved: Yes (First approved April 30th, 2009)
  • Brand name: Creon
  • Generic name: pancrelipase
  • Dosage form: Delayed-Release Capsules
  • Company: Solvay Pharmaceuticals, Inc.
  • Treatment for: Pancreatic Exocrine Dysfunction

Creon (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Development History and FDA Approval Process for Creon

Jun 14, 2011Approval Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
May  3, 2010Approval Abbott Receives FDA Approval for Creon to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy
May  1, 2009Approval Creon (pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines

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