FDA sinks Gaviscon "floating" claim

Executive Summary

Marion's petition to amend the final monograph for OTC antacid drug products to include the ingredient alginic acid and the labeling claim "floating" denied by FDA. Agency said its advisory review panel recognized that alginic acid-containing products may produce a layer of material floating on top of the contents of the stomach but concluded that there was insufficient evidence to support the claim that such a property contributes to the product's effectiveness. Gaviscon, which was approved via NDA, includes alginic acid as an inactive ingredient.