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"#1 prescribed" claim must be dropped from Zantac 75 package insert -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

ZANTAC 75 "#1 PRESCRIBED" CLAIM MUST BE DROPPED FROM PACKAGE INSERT, FDA said in its Dec. 19 approval letter to Glaxo Well-come. As one of four revisions to proposed labeling requested by the agency, the letter instructs Glaxo Wellcome to "delete the statement `Since 1988, the medicine in Zantac 75 has been the #1 prescribed acid reducer'" from the package insert. The Rx-to-OTC switch product will be marketed by Warner-Lambert under a joint-venture arrangement with Glaxo Wellcome.





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