Healthy Skepticism Library item: 5960

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Publication type: news

US FDA cancels advisory committee meeting to review Wyeth's desvenlafaxine data
Forbes 2006 Aug 22
http://www.forbes.com/markets/feeds/afx/2006/08/22/afx2965995.html

Full text:

US FDA cancels advisory committee meeting to review Wyeth’s desvenlafaxine data
08.22.2006, 04:18 PM

MADISON, N.J – Wyeth said the US Food and Drug Administration cancelled a Sept 7 committee meeting set to review data included in Wyeth’s New Drug Application for desvenlafaxine succinate’s extended release for the treatment of major depressive disorder.

‘After further review of the data, the FDA decided it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October,’ the company said.

‘Wyeth is encouraged by this development and believes that its comprehensive clinical trials program for desvenlafaxine succinate supports the product’s approval,’ it added.

It submitted its NDA to the FDA for desvenlafaxine succinate in December 2005.