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NDAC meeting

This article was originally published in The Tan Sheet

Executive Summary

Committee will meet in closed session April 23 to discuss "confidential trade secret information" with FDA and to receive an update from agency's drug review division. One day earlier, NDAC will consider Schering-Plough's three switch NDAs for non-sedating antihistamine Claritin (loratadine); the "primary purpose" of the April 22 meeting is to discuss chronic idiopathic urticaria as an OTC indication, FDA says...

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NDAC meeting

FDA's Pulmonary & Allergy, Dermatologic & Ophthalmologic Drugs Advisory Committees will join NDAC in deliberations on OTC switch of Schering-Plough's Claritin (loratadine). April 22 public meeting will focus on chronic idiopathic urticaria as an OTC indication (1"The Tan Sheet" March 18, 2002, In Brief). Committees also will meet in closed-door session April 23. Individuals wishing to speak at April 22 meeting must file written submissions by April 12...

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