Posted by Ritch on March 11, 2003, at 23:12:55
In reply to Re: Cymbalta/Duloxetine--Something's Up, posted by SLS on March 11, 2003, at 20:27:46
> 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
>
>
Scott, just a thought here, but maybe Lilly isn't in any really big hurry to get Cymbalta on the shelves while many are working through their Lexapro trials. They might do better by sitting on the sidelines for a few extra months while everyone goes through the Lex trials and then spring it when docs and patients have reached some firm conclusions about Lex's effectiveness/tolerability. IOW, it isn't going to help to burn money/time to get it to market more quickly..
poster:Ritch
thread:208072
URL: http://www.dr-bob.org/babble/20030310/msgs/208275.html