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Vivus Inc VVUSQ

VIVUS Inc is a US-based biopharmaceutical company engaged in developing and commercializing, next-generation therapies to address unmet medical needs in human health. Its commercial products include Qsymia, an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index; PANCREAZE which is a is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands, as well


OTCPK:VVUSQ - Post by User

Bullboard Posts
Post by gazoo999on Oct 19, 2012 7:52am
188 Views
Post# 20501767

VVUS Not ALLOWED IN EUROPE!!!!!

VVUS Not ALLOWED IN EUROPE!!!!!


NEWS RELEASE

VIVUS Receives Formal Decision From CHMP

MOUNTAIN VIEW, Calif., Oct. 18, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that is has received the formal opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following their October 15-18 meeting. As expected, the CHMP recommended against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union. The reasons for their decision were due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. The company currently intends to appeal this opinion and request a re-examination of the decision by the CHMP.

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