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FDA Claritin Hypospadia Review Targeted For Summer Completion

This article was originally published in The Tan Sheet

Executive Summary

FDA's review of safety and birth registry data to determine whether Schering-Plough's Claritin (loratadine) could be linked to hypospadia is expected to take approximately three months

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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

Claritin and hypospadia

FDA review of possible link between loratadine and birth defects "unlikely" to impact its decision on Schering-Plough's NDAs to switch Claritin OTC, agency says, noting many non-Rx products carry labeling restrictions concerning use during pregnancy. In addition to internal review being conducted by Division of Pulmonary & Allergy Drug Products and Office of Drug Safety, agency is consulting with outside experts in review of Swedish data, other information. FDA analysis, which extends to data for Rx Clarinex (desloratadine), could be completed by late September. Separate review by European Agency for the Evaluation of Medicinal Products is ongoing (1"The Tan Sheet" May 6, 2002, p. 3)...

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