FDA's Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus' weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.
Michael Rogawski, M.D., Ph.D. – Chair, Department of Neurology, UC-Davis
"Yes" on approval
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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