FDA ADVISORY COMMITTEE SPLITS ON FAMOTIDINE EFFICACY IN PREVENTING HEARTBURN
This article was originally published in The Tan Sheet
Executive Summary
FDA ADVISORY COMMITTEE SPLITS ON FAMOTIDINE EFFICACY IN PREVENTING HEARTBURN due to questions about the crossover design of several of Merck's studies. FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees split 4-4 on whether the data supporting the OTC switch indication for the prevention/reduction of heartburn was sufficient for approval.