The US Food and Drug Administration (FDA) has cleared PGxHealth's Viibryd tablets (vilazodone hydrochloride) for the treatment of major depressive disorder in adults.
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The tablets will be available in 10mg, 20mg and 40mg.
The most frequent adverse events reported by patients participating in clinical trials of Viibryd included diarrhoea, nausea, vomiting, and insomnia.
Viibryd and all other antidepressants have a boxed warning and a patient medication guide explaining the increased risk of suicidal thinking and behaviour in children, adolescents, and young adults ages 18 to 24 during initial treatment.
FDA Center for Drug Evaluation and Research Division of Psychiatry Products director Thomas Laughren said medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.
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