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Andrx loratadine

This article was originally published in The Tan Sheet

Executive Summary

Generics maker receives tentative FDA approval of ANDA (75-990) for orally disintegrating loratadine tablets (Schering's Claritin Reditabs) Nov. 15. Andrx previously was granted tentative approval for 24-hour loratadine/ pseudoephedrine combination (Claritin-D 24-Hour), for which it holds "first-to-file" status. Wyeth has said it holds FTF ANDA status for orally disintegrating loratadine (1"The Tan Sheet" Nov. 4, 2002, In Brief). FDA's target action date on Schering's switch NDAs for Claritin is Nov. 28; loratadine compound patent exclusivity expires Dec. 19...

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