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In Brief: OTC nizatidine, Zantac 75

This article was originally published in The Tan Sheet

Executive Summary

OTC nizatidine, Zantac 75: Whitehall-Robins' nizatidine Rx-to-OTC switch is "approvable," FDA notified the company on Nov. 30. The agency's Nonprescription Drug and Gastrointestinal Drugs Advisory Committees recommended that nizatidine 75 b.i.d. be approved for prevention of meal-induced heartburn at a Sept. 28 meeting ("The Tan Sheet" Oct. 2, p. 13). Glaxo-Wellcome was informed on Oct. 23 by FDA that its heartburn remedy Zantac 75 is "approvable." The nonprescription ranitidine Rx-to-OTC switch received an advisory committee recommendation in July ("The Tan Sheet" July 17, p. 4). The product will be marketed by Warner Wellcome under a joint venture agreement with Glaxo...

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