July 19, 2000

NDA 20-825: Zeldox (ziprasidone hydrochloride capsules)


Edmund P Harrigan, MD, Pfizer Global Research & Development    ppt   htm

Introduction, Thomas Laughren, MD,  FDA   htm

Background on QTc Prolongation, Arthur Moss, MD, Rochester Medical Center  ppt   htm

Clinical Important QT Interval Prolongation with Three Antipsychotics:  Thioridazine, Pimozine, Sertindole, G M Dubitsky, MD, FDA   PDF

Cardiovascular Drugs That Prolong the QT Interval, Douglas C Throckmorton, MD, FDA   ppt   htm

Assessing Cardiac Safety of Second-generation Antihistamines, Badrul A Chowdhury, MD, PhD, FDA   ppt   htm

QTc and Quinolones: Recent Regulatory Actions, Joyce Korvick MD, MPH, FDA  ppt   htm

Risk Intervention Study: Cisapride, Evelyn M Rodriguez, MD, MPH, FDA   ppt   htm

Open Public Hearing Speakers

Jacqueline Shannon, President, National Alliance for the Mentally Ill   pdf

Shannon Flynn, Consumer Member, National Alliance for the Mentally Ill   pdf