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Claritin Hives Relief Approval Could Close Out Rx Product Line

This article was originally published in The Tan Sheet

Executive Summary

Schering-Plough will not be granted marketing exclusivity for its OTC Claritin Hives Relief,following FDA approval Nov. 19

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Claritin ANDAs

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drug applications for Schering-Plough's Claritin Hives Relief Syrup (5 mg/5 mL loratadine) because the product "was not withdrawn from sale for reasons of safety or effectiveness," a notice in the Federal Register Feb. 2 states.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...

Claritin ANDAs

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drug applications for Schering-Plough's Claritin Hives Relief Syrup (5 mg/5 mL loratadine) because the product "was not withdrawn from sale for reasons of safety or effectiveness," a notice in the Federal Register Feb. 2 states.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...

Claritin ANDAs

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drug applications for Schering-Plough's Claritin Hives Relief Syrup (5 mg/5 mL loratadine) because the product "was not withdrawn from sale for reasons of safety or effectiveness," a notice in the Federal Register Feb. 2 states.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...

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