Pfizer ziprasidone
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Oral form of the antipsychotic agent, formerly known as Zeldox, is approved Feb. 5. A March launch is planned. Although the drug is not restricted to second-line use, labeling recommends physicians first consider prescribing other agents that have lower rates of QT prolongation. "Whether ziprasidone will cause torsades de pointes or increase the rate of sudden death is not yet known," labeling states. A boxed warning, recommended by FDA's Psychopharmacologic Drugs Advisory Committee, is not in labeling. Among the potential tradenames under discussion is Geodon. An intramuscular formulation of ziprasidone is scheduled for review by the psychopharm committee Feb. 1