Summary of Issues on Urticaria as an OTC Indication

5/14/02


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Table of Contents

Summary of Issues on Urticaria as an OTC Indication

Safety Criteria for OTC Drugs

Observations

Urticaria (hives) as an OTC Use

Urticaria (hives) as an OTC Use

Sponsor Proposal for an OTC Urticaria Indication

Other “Studies”: Consumer and Physician Surveys

Sponsor Proposal: Limit to CIU Population

Prior Experience with Restriction to Physician Diagnosed Population

Problems with this Approach

Issues for the Committee

Author: CDER USER