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Zenpep Approval History

FDA Approved: Yes (First approved August 27, 2009)
Brand name: Zenpep
Generic name: pancrelipase
Dosage form: Capsules
Previous Name: Zentase
Company: Allergan plc
Treatment for: Pancreatic Exocrine Dysfunction

Zenpep (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 History and FDA Approval Process for Zenpep

DateArticle
Aug 28, 2009Approval Eurand Granted FDA Approval for Zenpep
Jun 19, 2008Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
Feb 21, 2008Eurand Granted Priority Review for Zentase NDA
Dec 20, 2007Eurand Completes New Drug Application for Zentase
Jun 12, 2007Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency

Further information

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