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Claritin Label May Not Need Physician Diagnosis Statement – Consultant

This article was originally published in The Tan Sheet

Executive Summary

Physician diagnosis instructions on OTC Claritin labeling would not be necessary if the second generation, non-sedating antihistamine is approved by FDA for a general hives or urticaria claim, according to William Rosenberg, MD, University of Tennessee

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Loratadine Clinical Trials On General Hives Suggested By NDAC Members

An OTC switch of Schering-Plough's non-sedating antihistamine Claritin for general hives would require data from an evidence-based study of acute urticaria, Jesse Joad, MD, UC-Davis Medical Center, asserted at a meeting of FDA's Nonprescription Drugs Advisory Committee April 22

Loratadine Clinical Trials On General Hives Suggested By NDAC Members

An OTC switch of Schering-Plough's non-sedating antihistamine Claritin for general hives would require data from an evidence-based study of acute urticaria, Jesse Joad, MD, UC-Davis Medical Center, asserted at a meeting of FDA's Nonprescription Drugs Advisory Committee April 22

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