Posted by SLS on February 26, 2003, at 19:56:10
In reply to If Cymbalta is so good, why isnt it out yet? (nm), posted by Jack Smith on February 26, 2003, at 0:22:50
Hi jack.
The FDA issued Eli Lilly what is called an "approvable letter". I think this means that the drug has met the requirements for safety and efficacy for the indication it was applied for. It is usually the intent of the FDA to approve it pending issues involving the wording of the label "package insert" and manufacturing.
I spoke to a customer service representative and a clinical investigator at Lilly about the release of Cymbalta. Neither was able to fix a date, only that it should be this year. I bet it becomes available within the next 3 months. I hope so. It's the drug I would like to try next.
- Scott
poster:SLS
thread:133959
URL: http://www.dr-bob.org/babble/20030224/msgs/204136.html