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Switch Petitions Must Come From NDA Holders, CHPA Says

This article was originally published in The Tan Sheet

Executive Summary

Drug manufacturers, with the guidance of FDA, are the only qualified parties to gather the data necessary to establish that a drug can be safely used without a prescription, the Consumer Healthcare Products Association asserts.

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Pfizer

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

Pfizer

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

Pfizer

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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