Claritin ANDAs

Executive Summary

FDA has determined it may approve abbreviated new drug applications for Schering-Plough's Claritin Hives Relief Syrup (5 mg/5 mL loratadine) because the product "was not withdrawn from sale for reasons of safety or effectiveness," a notice in the Federal Register Feb. 2 states. Schering received approval for the product in November 2003 (1"The Tan Sheet" Nov. 24, 2003, p. 9). Although the firm sells a Hives Relief tablet, the syrup formulation was never marketed. The decision by the agency came in response to a February 2005 citizen petition submitted by Silarx Pharmaceuticals. The syrup will continue to be listed on the "Discontinued Product List" section of the Orange Book, FDA says...