FDA approves new schizophrenia drug

May 6, 2009 at 5:53 PM
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WASHINGTON, May 6 (UPI) -- The U.S. Food and Drug Administration has approved Fanapt tablets to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.

"Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Dr. Thomas Laughren, director of the FDA's division of psychiatry products. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives."

The federal agency said Fanapt (iloperidone) is included in the atypical antipsychotic class of drugs and will carry a boxed warning alerting prescribers to an increased risk of death associated with off-label use of the drug to treat behavioral problems in older people with dementia-related psychosis. Fanapt is not approved for patients with dementia-related psychosis.

Fanapt is manufactured by Patheon Inc. of Mississauga, Ontario, Canada, for Vanda Pharmaceuticals Inc. of Rockville, Md.

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