FDA approves cariprazine for schizophrenia, bipolar disorder

FDA approved an NDA for Vraylar cariprazine ( RGH-188) from Allergan plc (NYSE:AGN) and Gedeon Richter Ltd. (Budapest:RICHTER) to treat schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder.

The approval comes with a boxed warning noting an increased risk of death associated with the use of antipsychotics in older patients with dementia-related psychosis. ...