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Article: [1] Pharmacia & Upjohn Receives FDA Approvable Letter for VESTRA(TM).
- Article from:
- PR Newswire
- Article date:
- April 7, 2000
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PEAPACK, N.J., Feb. 23 /PRNewswire/ --
Pharmacia & Upjohn announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for the company's new antidepressant, VESTRA(TM) (reboxetine mesylate tablets).
This action requires the company to conduct an additional U.S. 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 U.S. Pharmacia & Upjohn is in the process of planning this additional U.S. study.
"We are confident about fulfilling the FDA's new request and look forward to ...