This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryThe sepsis biologic will be reviewed by FDA's Anti-Infective Drugs Advisory Committee Sept. 12. Drotrecogin alfa initially was to be reviewed July 17, but the meeting was delayed when the agency extended the user fee date for the product from July 27 to Oct. 27 to allow more time for evaluation. Lilly has entered an agreement with Syncor for an "emergency response delivery service" for Xigris that would supply the product to most hospitals within three hours
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