FDA Extends Review Period For Eurand's ZENPEPTM Pancreatic Enzyme Replacement Therapy

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Jun 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has advised the Company that it has extended the June 2009 user fee goal date for the New Drug Application for ZENPEP™ (pancrelipase capsules) by three months.

The FDA did not request that the Company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.

About ZENPEP (pancrelipase capsules)

ZENPEP is a proprietary pancreatic enzyme product developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The product was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. ZENPEP is a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion.

Source
Eurand