505(b)(2) Product Gains Revenue with FDA Actions Against DESI’s
- Posted by: Ken Phelps
- Published on: May 19, 2010
Eurand reported improved financial performance for the 1st quarter of 2010. CEO Gearoid Faherty indicated the majority of the revenue gains could be attributed to Zenpep®, Eurand’s delayed-release pancreatic insufficiency drug. Zenpep was approved in August 2009. The FDA has recently clamped down on unapproved pancreatic enzymes that have been on the market for years. In October 2007 FDA established the date of April 2010 for all makers of unapproved pancreatic enzymes to cease distribution.
This is yet another example to bolster the confidence of investors in 505(b)(2). Until 2008, investors were leery of investing in projects to gain NDA approval of the unapproved DESI’s because they were uncertain FDA would remove the competitor DESI’s from the market once their NDA was approved.