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Loratadine approvals

This article was originally published in The Tan Sheet

Executive Summary

Wyeth Consumer Care's ANDA 75-822 for orally disintegrating 10 mg loratadine tablets (equivalent to Schering-Plough's Claritin RediTabs) approved by FDA Feb. 10 with180 days of marketing exclusivity. Wyeth already markets the same product under the brand name Alavert, which was approved under a 505(b)(2) application in December (1"The Tan Sheet" Dec. 23, 2002, p. 5). Separately, Andrx's ANDA 75-706 for loratadine 10 mg/pseudoephedrine 240 mg combination, approved Feb. 21, also receives 180-day exclusivity. Andrx will supply Perrigo with the product, which plans to ship the Claritin-D 24-Hour equivalent in mid-June (2"The Tan Sheet" Feb. 3, 2003, p. 13)...

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