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Allegra pediatric sNDA

Executive Summary

FDA adds data on pediatric patients ages six months to less than six years to Aventis' Allegra label May 12. Aventis conducted studies in response to written request by FDA. The company acknowledged that Allegra sales have been hurt by the inability to make a pediatric-friendly syrup formulation of fexofenadine (1"The Pink Sheet" May 12, p. 16)....

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