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Antihistamine cough/cold claims

This article was originally published in The Tan Sheet

Executive Summary

NDMA requests "feedback" meeting with FDA to discuss cough/cold claims for antihistamines. In February letter to the agency, NDMA notes that it submitted information on OTC antihistamines as cold remedies in June 1992, but FDA has not yet responded to the data. In its December 1992 final monograph for OTC Antihistamine Drug Products, FDA did not discuss the issue of antihistamine claims for symptoms of the common cold.
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