VIVUS Announces Acceptance of Qsymia Decentralized Marketing Authorization Application in Europe
VIVUS (VVUS)
Last vivus earnings: 3/3 04:05 pm
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US:NASDAQ Investor Relations:
ir.vivus.com/node/5806
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Source: GlobeNewswire
CAMPBELL, Calif., Oct. 07, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS) (the “Company”), a biopharmaceutical company, announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland (the “Concerned Member States”) have accepted the Marketing Authorization Application (the “MAA”) for Qsymia (phentermine and topiramate extended-release) on a decentralized basis, with Sweden acting as the lead Concerned Member State, also known as the Reference Member State, for purposes of assessing the MAA. Under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries. “With the growing body of real world evidence supporting the safety and efficacy of Qsymia and its recent approval in the Republic of Korea, we believe that there is growing recognition of the benefit that this therapy can provide to patient
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