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