FDA approves Latuda

SILVER SPRING , Md. (Oct. 29) The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.

The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, director of the FDA division of psychiatry products. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available."

The drug includes a boxed warning, the highest-level warning that can appear on a drug label, to warn prescribers of the risk of death associated with off-label prescribing of the drug for behavioral problems in elderly people with dementia-related psychosis.