In Brief: Antiflatulant labeling
This article was originally published in The Tan Sheet
Executive Summary
Antiflatulant labeling: FDA issues March 5 final rule amending the antiflatulant drug products monograph by adding the following possible statements of identity: "antiflatulant," "antigas," or "antiflatulant (antigas)." The rule also revises the allowable indications to include "alleviates [or relieves] the symptoms referred to as gas" or "alleviates [or relieves] bloating, pressure, fullness, or stuffed feeling, commonly referred to as gas." In addition, the rule states: "Antigas...may be used interchangeably with the term antiflatulant. Neither term should be considered as describing the mechanism of action of the active ingredient contained in the product." Comments on the amendment to the final rule must be received by FDA no later than June 3...