Antihistamine OTC Switch Petition Slated For NDAC Debate May 11
This article was originally published in The Tan Sheet
Executive Summary
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.
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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.
Switch Petitions Must Come From NDA Holders, CHPA Says
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.