Ultresa Approval History

  • FDA approved: Yes (First approved March 1st, 2012)
  • Brand name: Ultresa
  • Generic name: pancrelipase
  • Company: Aptalis Pharma U.S. Inc.
  • Treatment for: Pancreatic Exocrine Dysfunction

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

FDA Approval History for Ultresa

DateArticle
Mar  1, 2012Approval Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules

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