Labeling clarity on OTC nizatidine heartburn prevention claim urged by NDAC members.
This article was originally published in The Tan Sheet
Executive Summary
OTC NIZATIDINE LABELING CLARITY ON HEARTBURN PREVENTION CLAIM URGED by Nonprescription Drugs Advisory Committee member Eric Brass, MD/PhD, Harbor-UCLA Medical Center, at the Sept. 28 meeting on Whitehall-Robins' Rx-to-OTC switch application. Brass noted that the proposed package labeling for the product, features the terms "acid reducer" and "heartburn" relatively prominently, but "you have to look real hard to see `prevents'," he noted.