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Antihistamine switch

This article was originally published in The Tan Sheet

Executive Summary

CDER expects to reach decision by year-end on whether to switch Rx low- and non-sedating antihistamines Claritin (Schering-Plough), Allegra (Aventis) and Zyrtec (Pfizer) without sponsor consent. In May, FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees found the drugs safe for use in an OTC setting. Issues related to sedation warnings on currently available OTC antihistamines were discussed at a joint FDA/NTSB meeting Nov. 14-15 (1"The Tan Sheet" Nov. 19, p. 3)...
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