Posted by SLS on March 11, 2003, at 20:27:46
In reply to Re: Cymbalta/Duloxetine--Something's Up, posted by jrbecker on March 11, 2003, at 13:25:22
Hi y'all.
I spoke to Lilly earlier today. Their marketing representative cooraborated what I had heard or read previously. The FDA is holding up approval of duloxetine pending evaluation of their manufacturing process. There are no issues regarding labelling. Lilly was granted an approvable letter by the FDA in September. This means that safety and efficacy have been firmly established in their estimation. It sure is taking a long time.
- Scott
poster:SLS
thread:208072
URL: http://www.dr-bob.org/babble/20030310/msgs/208219.html