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news.France-based pharmaceutical company Servier has announced that the European Commission has granted marketing authorization for the company's Valdoxan/Thymanax, a melatonergic antidepressant for the treatment of adult patients with major depressive episodes.
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The European approval of Valdoxan is based on both short- and long-term results from a large, comprehensive, international development program including almost 6,000 adult patients with depression, said Servier. The results demonstrate the superior efficacy of Valdoxan as compared with placebo, selective serotonin reuptake inhibitors and serotonin noradrenaline reuptake inhibitor treatments, the company added.
Following approval from the European Commission, Valdoxan is expected to become commercially available in European countries shortly. Valdoxan was discovered and developed by Servier.