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
OTC Switch Public Health Arguments Tougher In Light Of FDA Stance
Public health arguments supporting OTC switches for chronic indications become more difficult in light of FDA's refusal to consider economic implications for switching second-generation antihistamines, a J&J/Merck rep said June 11.
Antihistamine OTC Switch Petition Slated For NDAC Debate May 11
FDA's decision to bring a citizen petition seeking OTC status of three low- and non-sedating antihistamine drugs before NDAC may be an attempt to apply public pressure on Schering-Plough, Aventis and Pfizer to accelerate any plans they may have to initiate switches on their own.