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Pertzye FDA Approval History

FDA Approved: Yes (First approved May 17, 2012)
Brand name: Pertzye
Generic name: pancrelipase
Dosage form: Delayed Release Capsules
Company: Digestive Care, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Pertzye (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.

Development timeline for Pertzye

May 18, 2012Approval Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
Oct 27, 2008Digestive Care, Inc. Announces the Complete Submission of the NDA for Pancrecarb (pancrelipase)
Jul  7, 2008Digestive Care, Inc. Announces the Filing of the First Module ofNDA Submission for Pancrecarb (pancrelipase)

Further information

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