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Sertindole was the subject of an F DA advisory panel review in April, which voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia but only for a subgroup of patients yet to be defined.
If approved, Lundbeck will market sertindole in the United States as Serdolect.
The panel voted 8-2 to urge the FDA to make the drug, Serdolect, available for certain patients who need new options to battle the serious disease that causes hallucinations, delusions, and disorganized thought.