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.