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Generic Claritin-D

This article was originally published in The Tan Sheet

Executive Summary

Andrx receives tentative FDA approval July 9 for 24-hour loratadine/pseudoephedrine combination. Generics company is believed to be first to file an ANDA for equivalent to Schering-Plough's Claritin-D 24-Hour; Impax Labs was first to file for 12-hour formulation and has entered into contract manufacturing, supply agreement with Schering for OTC distribution (1"The Tan Sheet" July 1, 2002, p. 4). Andrx, Impax are defendants in Schering's ongoing patent litigation. Separately, Schering announces July 8 approval in Japan for Rx sale of Claritin 10 mg tablets...

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