VIVUS, Inc.
VVUS today announced that based on preliminary feedback from the
European Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP), the company expects an opinion recommending against approval of
the Marketing Authorization Application (MAA) for Qsiva™
(phentermine/topiramate ER) for the treatment of obesity. The formal decision
from the CHMP is expected following their October 2012 meeting. If a negative
recommendation is issued in October, and depending upon the nature of the
objections, the company will either resubmit the MAA at a later date or appeal
this decision and request a re-examination by the CHMP.
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