Eurand (EURX) Receives Approvable Letter From FDA for EUR-1008 (Zentase)
More News related to EURX
- Eurand to Present At Thomas Weisel Partners Healthcare Conference 2008
- Eurand Reports Recent Developments and Second Quarter 2008 Financial Results
- Eurand to Receive $35 Million Payment and Litigation Settlement
- Eurand Enters Agreement With Daewoong Pharmaceutical Co. Ltd (South Korea) for Once-Daily Extended Release Muscle Relaxant
- Eurand Announces Conference Call On Second Quarter 2008 Financial Results
Eurand N.V. (Nasdaq: EURX) announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI).
The letter marks notable progress towards gaining approval and does not require Eurand to conduct additional clinical trials prior to approving EUR-1008. In addition, the FDA recently completed a successful pre-approval inspection (PAI) of the Company's manufacturing facilities. Eurand is working with the FDA to provide a full and timely response to the agency's requests, and based on current information, the company still anticipates that it will be in a position to launch EUR-1008 in the second half of 2008.
Related Categories
Corporate NewsFDA
Stocks Mentioned
+0.15Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
