FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Gastrointestinal Drugs Advisory Committee (GIDAC)
The Committee will discuss a supplemental new drug application for XELJANZ (tofacitinib) tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy
The Committee unanimously supported, by a vote of 17-Yes to 0-No, with no abstentions, the safety and efficacy of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, submitted by Intercept Pharmaceuticals, Inc. The Prescription Drug User Fee Act (PDUFA) goal date for the related new drug application is May 29, 2016.
Gastrointestinal Drugs Advisory Committee (GIDAC)
GIDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.