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Nonsedating antihistamines

This article was originally published in The Tan Sheet

Executive Summary

FDA has yet to reach a decision on a Blue Cross exec's petition requesting the agency switch to OTC status Schering-Plough's Claritin, Hoechst Marion Roussel's Allegra and Pfizer's Zyrtec Rx allergy medications. The citizen petition, which suggests the Rx products are safer than currently available OTC antihistamine/decongestants, "raises complex issues requiring extensive review and analysis," FDA tells petitioner Robert Seidman, pharmacy VP at Blue Cross of California, in a Jan. 20 letter. Seidman recently urged the drug marketers to forward him data submitted for switch NDAs for the products in Europe and Canada ("The Tan Sheet" Jan. 25, p. 20)

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