Allergan Plc said on Thursday the U.S. Food and Drug Administration approved its new antipsychotic drug to treat bipolar disorder and schizophrenia.
The drug, Vraylar, carries a boxed warning on increased risk of death associated with its use in older people with dementia-related psychosis, the FDA said on its website.
Vraylar was approved after showing efficacy in more than 2,700 adults, the company said.
The new drug will be the second antipsychotic to be sold by Allergan. The company already sells Viibryd to treat major depressive disorder in adults.
Allergan partnered Gedeon Richter Plc to develop Vraylar.
The company's shares were little changed at $301.02 in afternoon trade on Thursday.