Schering OTC Claritin Will Launch In December Without Rx Transition Period
Executive Summary
Schering-Plough prescription Claritin availability will not overlap with OTC loratadine once the switched drug becomes available in December
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Forced OTC switch issue returns to FDA
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...
Forced OTC switch issue returns to FDA
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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