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This article was originally published in The Tan Sheet

Executive Summary

Zyrtec-D 12-Hour Extended Release Tablets (cetirizine 5 mg/pseudoephedrine 120 mg) approved Aug. 10 for relief of symptoms associated with seasonal/perennial allergic rhinitis in adults and children 12 and older. FDA notes that although application is approved with "Rx-only" labeling, "the issue of the most appropriate marketing status for Zyrtec Tablets, Zyrtec Syrup and Zyrtec-D 12-Hour Extended Release Tablets is under review by the agency." FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees have found Zyrtec, Schering-Plough's Claritin and Aventis' Allegra to be safe for OTC use despite sponsors' opposition to switches (1"The Tan Sheet" May 14, p. 5). Zyrtec-D offers Pfizer potential to remain in Rx allergy market if forced to switch a drug in the line

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