Wyeth OTC loratadine “approvable”
This article was originally published in The Tan Sheet
Executive Summary
FDA deems firm's application for Alavert, an OTC version of Schering-Plough's Claritin Reditabs (loratadine), approvable July 3. Alavert will employ CIMA Labs' DuraSolv technology; CIMA announced an exclusive license, supply agreement with Wyeth June 27 ("1The Tan Sheet" July 1, 2002, p. 4). Wyeth filed an NDA under section 505(b)(2) in January; McNeil also filed a 505(b)(2) application in November. Schering sued both companies for patent infringement 2("The Tan Sheet" Feb. 4, 2002, p. 3)...