Vivus’s Qnexa Gets Thumbs Down From Mixed FDA Panel

Ruthanne Williams Roussel submits:

As many will know by now, an FDA briefing panel July 15 recommended against approval of Vivus’ (VVUS) obesity drug candidate Qnexa by a vote of 10 to 6. This was originally announced as a vote of 9 to 7, but a new electronic voting system was in use, and it must have been a little confusing, because one panelist later claimed that they had unintentionally voted "Yes" for approval instead of "No" against. (Insert "Jim, I’m a doctor, not an electronic voter!" joke here.)

The main concerns cited about Qnexa were:


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