REMS trips Qnexa with 3-month delay; but no hint of CVOT requirement
This article was originally published in Scrip
That highly anticipated 17 April date Wall Street and patients seeking a new weight-loss therapy have been watching is now moot, with US regulators declaring they need at least three more months to review Vivus' new drug application (NDA) for Qnexa (phentermine/topiramate), after the Mountain View, California-based company submitted a risk evaluation and mitigation strategy (REMS) plan to the US FDA earlier this month.
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