Posted by dove on March 6, 2000, at 8:44:13
In reply to reboxetine, posted by Tom on March 5, 2000, at 22:11:48
This was sent out yesterday, looks good!
dove
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FDA Approvable Letter Received for Vestra
February 28, 2000
MedscapeWirePharmacia & Upjohn announced today that the US Food and Drug Administration (FDA) has issued a second approvable letter for the company's new antidepressant, Vestra (reboxetine mesylate tablets).
This action requires the company to conduct an additional US clinical study to augment the original New Drug Application (NDA) for VESTRA. The original NDA was accepted for filing by FDA in June 1998, based on studies conducted outside the United States. Pharmacia & Upjohn is in the process of planning this additional US study.
"We are confident about fulfilling the FDA's new request and look forward to bringing this important new class of antidepressants to the US market," said Carrie Cox, executive vice president of Global Business Management.
Vestra is currently marketed by Pharmacia & Upjohn in 18 countries.
poster:dove
thread:26073
URL: http://www.dr-bob.org/babble/20000302/msgs/26106.html