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Re: Reboxetine Vestra 'not approvable' cromwell

Posted by kazoo on May 23, 2001, at 2:41:51

In reply to Re: Reboxetine Vestra 'not approvable', posted by cromwell on May 22, 2001, at 15:25:30

> PEAPACK, N.J., May 18 /PRNewswire/ -- Pharmacia Corporation announced today that it has received a "not approvable" letter from the U.S. Food and Drug Administration (FDA) for VESTRA (reboxetine mesylate tablets), the company's investigational antidepressant.
Gee, why doesn't this surprise me?

> The company also announced that the FDA has agreed to convene an advisory committee meeting of outside experts SHORTLY BEFORE YOU DIE to review the VESTRA submission.

The article isn't clear as to why it was deep-sixed. From what I gather, the thumbs-down was because of certain "clinical studies" abroad?

"Kazoo, would you like to study abroad?"
"Yes, teacher, I would like to study a broad."

Do I smell a rat in the Eli Lilly Corporation? I bet their stocks soared from this announcement.

(a studious) kazoo




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