VIVUS Announces Approval Of Qsymia In The Republic Of Korea Nasdaq:VVUS

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“VIVUS and our partner Alvogen are proud that the South Korean MFDS has approved Qsymia as a safe and effective pharmaceutical to help people in the search for a healthier BMI,” said John Amos, CEO of VIVUS. “The MFDS authorization followed a robust overview of existing Qsymia clinical trial and protection security data and does not require additional safety-related post marketing clinical studies. In September 2017 Under an agreement executed, Alvogen, a prominent innovator in the Korean anti-obesity market, is solely accountable for obtaining and maintaining regulatory approvals and for all marketing and sales activities in Korea.

The aftereffect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in mixture with other products intended for weight loss, including prescription and over-the-counter drugs, and organic preparations, never have been set up. Qsymia can cause fetal damage. Females of reproductive potential should have a negative being pregnant test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy.

If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the individual should be up to date of the potential risk to the fetus. The most commonly observed side effects in controlled clinical studies, 5% or higher with least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dried out mouth area. VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.

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