Ultresa and Viokace Approved for Exocrine Pancreatic Insufficiency

Aptalis Pharma announced that the FDA has approved Ultresa (pancrelipase delayed release capsules) and Viokace (pancrelipase tablets) for the treatment of exocrine pancreatic insufficiency.

Ultresa is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions. Ultresa is available in three color coded capsule strengths. Each capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

  • 13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase
  • 20,700 USP units of lipase; 41,400 USP units of protease; 41,400 USP units of amylase
  • 23,000 USP units of lipase; 46,000 USP units of protease; 46,000 USP units of amylase

Viokace is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Each Viokace tablet strength contains the specified amounts of lipase, protease, and amylase as follows:

  • 10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase
  • 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase

For more information visit www.aptalispharma.com.