FDA approves Lundbeck's antidepressant Brintellix

Sept 30 Mon Sep 30, 2013 6:24pm EDT

Sept 30 (Reuters) - The U.S. Food and Drug Administration approved Lundbeck's antidepressant Brintellix to treat adults with major depressive disorder.

The drug, which Lundbeck will co-market with Japanese partner Takeda Pharmaceutical Co Ltd, will be available in four doses.

Brintellix, like other antidepressants, will carry a boxed warning alerting patients and doctors to an increased risk of suicidal thoughts and behavior in children, adolescents and young adults aged 18-24 during initial treatment.

The most common side effects reported by patients taking the drug - generically known as vortioxetine - include nausea, constipation and vomiting.

Major depressive disorder is characterized by mood changes that may interfere with a person's ability to carry out to day-to-day activities. Symptoms also include increased fatigue and feelings of guilt or worthlessness.

A couple walks along the rough surf during sunset at Oahu's North Shore, December 26, 2013. REUTERS/Kevin Lamarque

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