Approvable Letter Issued to Eurand

Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI).  The company did not state the FDA’s reasoning for the approvable status, but did say that the agency was not requiring additional clinical trials.   The letter comes after what the company termed a successful pre-approval inspection of its manufacturing facilities. 

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in Approvable Letters. Bookmark the permalink.

Comments are closed.