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Executive Summary

The agenda of the upcoming Nov. 19 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to consider recommending approval of Pfizer's antidepressant drug sertraline tells little, if any, about FDA's concerns with the drug. FDA says in the tersely worded agenda that the division of Neuropharmacological Drug Products "has reviewed the NDA submitted by Pfizer for sertraline and, before forwarding a recommendation to the Office of Drug Evaluation I...seeks the committee's advice" on two questions: Has Pfizer provided evidence from more than one clinical study that supports efficacy of the drug for depression?; and has Pfizer provided evidence of the drug's safety? The agenda is typical of FDA's Neuropharmacological Drug Products Division. The division does not identify specific approval issues in advisory committee agenda questions. Sertraline will be the second of the serotonin reuptake inhibitors for depression to make it to an FDA advisory committee review. Lilly's Prozac was the first serotonin uptake inhibitor reviewed and approved by FDA. Prozac was reviewed by an advisory committee five years ago, in October 1985. The full NDA review for the Lilly drug took four-and-a-half years. The sertraline NDA has been pending at FDA for two-and-a-half years.



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