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applications for Schering-Plough's Claritin Hives Relief Syrup (5 mg/5 mL loratadine) because the product "was not withdrawn from sale for reasons of safety or effectiveness," a notice in the Federal Register Feb. 2 states.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

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Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports

Schering-Plough's post-approval commitments for OTC Claritin include submitting to FDA reported cases of the birth defect hypospadia following maternal ingestion of loratadine, the company said

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