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In Brief: Schering-Plough's Claritin

Executive Summary

Schering-Plough's Claritin: Loratadine syrup (10 mg per 10 mL, NDA 20-641) is approved by FDA Oct. 14 for use in patients six years of age and older. Schering touts Claritin as "the first and only nondrowsy antihistamine syrup for children"; Pfizer's antihistamine Zyrtec (cetirizine) was approved in a syrup formulation for children age six and older Sept. 27 ("The Pink Sheet" Oct. 7, In Brief). The children's dosage for Claritin is 10 mg syrup (two teaspoonsful) once daily, labeling states. The approved indication for Claritin 10 mg tablets has also been expanded to children age six and older...



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