Searle Celebrex APC Trial Could Be Sufficient For SAP Indication – FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Searle’s recently initiated Adenoma Prevention with Celecoxib (APC) study could be adequate to support a Celebrex indication for spontaneous adenomatous polyposis (SAP), FDA said in review documents for the drug’s familial adenomatous polyposis (FAP) indication.