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In Brief: Tavist-D for colds

This article was originally published in The Tan Sheet

Executive Summary

Tavist-D for colds: TV advertising for Sandoz' OTC clemastine fumerate allergy medication touts the recent recommendation by FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees that the ingredient be approved for the treatment of the common cold. FDA has not approved a cold indication for Tavist-D and Sandoz did not have an NDA on file when the recommendation was made ("The Tan Sheet" Nov. 20, p. 5). Sandoz issued a press release Feb. 21 announcing that "for the first time, two well-controlled clinical studies have proven that an antihistamine significantly reduces cold symptoms." The release, handled by Publicis Public Relations, Dallas, also mentions the advisory committee recommendation, noting that "clemastine fumerate is the only 12-hour antihistamine proven cold-effective"...

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