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Antihistamine Forced Switch Proposal Returns In Citizen Petition

This article was originally published in The Tan Sheet

Executive Summary

A law firm seeks to cut its own health care costs as well as direct FDA's attention to previous citizen petitions to switch Rx antihistamines to OTC with a petition asking FDA to switch Sanofi-Aventis's Allegra and Pfizer's Zyrtec

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FDA approved Johnson & Johnson's bid to switch prescription antihistamine/nasal decongestant Zyrtec-D to nonprescription status, but the firm is still awaiting a reply on single-ingredient Zyrtec

Antihistamine switch petition gains support

Consumers Union, the non-profit publisher of Consumer Reports, supports a recent petition by law firm Greenberg Traurig to switch Rx antihistamines Allegra (Aventis) and Zyrtec (Pfizer) to OTC status in a letter to FDA July 11. "The consumer cost benefit of having these drugs available over-the-counter outweigh any possible risks," Consumers Union says, adding the move would be consistent with FDA switch policy. "Specifically, the potential for misuse and abuse is low, consumers can use the drugs for self or previously diagnosed conditions, the drugs can be adequately labeled, and health practitioners are not needed to provide for the safe and effective use of the products," the group notes. In its petition to FDA March 12, Greenberg Traurig cited previous citizen petitions in pressing the agency to switch the drugs (1"The Tan Sheet" March 26, 2007, p. 3) ...

Clarinex Clinical, Safety Characteristics Support OTC Use – WellPoint

The similar safety and efficacy profile of Schering-Plough's follow-on drug Clarinex (desloratadine) to other second-generation antihistamines makes it appropriate for OTC availability, WellPoint Health Networks asserts in an April 15 petition to FDA

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