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Forced OTC switch issue returns to FDA

Executive Summary

A new citizen's petition asks FDA to switch two antihistamines, Sanofi-Aventis' Allegra and Pfizer's Zyrtec, to OTC status. The petition, filed March 12 by attorney Joel Stocker of Greenberg Traurig, makes the case that the "positive OTC experience" of Schering-Plough's Claritin "has made the case to switch [Allegra and Zyrtec] even more compelling." Schering initially fought a Wellpoint petition to force an OTC switch of Claritin (along with Allegra and Zyrtec), but later filed a sNDA to switch Claritin (1"The Pink Sheet" Dec. 2, 2002, p. 7). FDA previously declined to act on the petitions for Allegra and Zyrtec...

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