Eurand NV, a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the US 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.

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.

Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies.