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Zantac Efferdose

This article was originally published in The Tan Sheet

Executive Summary

Warner-Lambert receives FDA approval March 8 for an efficacy supplement to NDA 20-745 for the labeled indication "For the prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages." The effervescent tablet (ranitidine 75 mg) was cleared Feb. 26, 1998 for heartburn treatment ("The Tan Sheet" March 2, 1998, p. 1). The launch of the product is still pending. Warner-Lambert may have been awaiting approval of the prevention indication before introducing the line extension to Zantac 75

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