FDA Approves Drug for Depressive Disorder

FDA has approved PGxHealth's depressive disorder drug. The tablets will be available in three specifications.

The US FDA has approved PGxHealth's Viibryd tablets (vilazodone hydrochloride) for the treatment of major depressive disorder in adults. The tablets will be available in 10mg, 20mg and 40mg.

Major depressive disorder, also called major depression, is characterised by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities.

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,